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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85630105 | 8563010 | 5 | F | 20160919 | 20120515 | 20160927 | EXP | US-ROCHE-650763 | ROCHE | , SULKOWSKI M SCIENTIFIC RATIONALE AND STUDY DESIGN OF THE INDIVIDUALIZED DOSING EFFICACY VS FLAT DOSING TO ASSESS OPTIMAL PEGYLATED INTERFERON THERAPY (IDEAL) TRIAL: DETERMINING OPTIMAL DOSING IN PATIENTS WITH GENOTYPE 1 CHRONIC HEPATITIS C. JOURNAL OF VIRAL HEPATITIS 2008;15:475-481. | 0.00 | Y | 0.00000 | 20160927 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85630105 | 8563010 | 1 | PS | Peg-Interferon Alfa 2a | PEGINTERFERON ALFA-2A | 1 | Unknown | U | 103964 | 180 | UG | SOLUTION FOR INJECTION | /wk | ||||||
| 85630105 | 8563010 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | DOSE: 1000-1200 MG/DAY OR 1000-1200 MG/DAY | U | 21511 | TABLET | ||||||||
| 85630105 | 8563010 | 3 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Unknown | 1.5 UG/KG/WEEK OR 1 UG/KG/WEEK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85630105 | 8563010 | 1 | Hepatitis C |
| 85630105 | 8563010 | 2 | Hepatitis C |
| 85630105 | 8563010 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85630105 | 8563010 | OT |
| 85630105 | 8563010 | DE |
| 85630105 | 8563010 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85630105 | 8563010 | Anaemia | |
| 85630105 | 8563010 | Blood disorder | |
| 85630105 | 8563010 | Cardiovascular disorder | |
| 85630105 | 8563010 | Death | |
| 85630105 | 8563010 | Depression | |
| 85630105 | 8563010 | Gastrointestinal disorder | |
| 85630105 | 8563010 | Hepatobiliary disease | |
| 85630105 | 8563010 | Infection | |
| 85630105 | 8563010 | Lymphopenia | |
| 85630105 | 8563010 | Mental disorder | |
| 85630105 | 8563010 | Myocardial infarction | |
| 85630105 | 8563010 | Neoplasm | |
| 85630105 | 8563010 | Nervous system disorder | |
| 85630105 | 8563010 | Neutropenia | |
| 85630105 | 8563010 | Respiratory disorder | |
| 85630105 | 8563010 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |