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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280361 | 12628036 | 1 | I | 20160801 | 20160807 | 20160807 | EXP | CN-ROCHE-1806993 | ROCHE | JI D, CHEN G-F, WANG C, WANG Y-D, SHAO Q, LI B, ZHAO J, YOU S-L, HU J-H, LIU J-L, NIU X-X, CHEN J, LU L, WU V AND LAU G TWELVE-WEEK RIBAVIRIN-FREE DIRECT-ACTING ANTIVIRALS FOR TREATMENT-EXPERIENCED CHINESE WITH HCV GENOTYPE 1B INFECTION INCLUDING CIRRHOTIC PATIENTS. HEPATOLOGY INTERNATIONAL 2016 JUL 21;:1-10. | 0.00 | Y | 0.00000 | 20160808 | OT | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126280361 | 12628036 | 1 | PS | Peg-Interferon Alfa 2a | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 180 OR 135 MICROGRAM | U | 103964 | /wk | ||||||||
| 126280361 | 12628036 | 2 | SS | Peg-Interferon Alfa 2a | PEGINTERFERON ALFA-2A | 1 | U | 103964 | |||||||||||
| 126280361 | 12628036 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 0 | 15 | MG/KG | ||||||||
| 126280361 | 12628036 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126280361 | 12628036 | 1 | Chronic hepatitis C |
| 126280361 | 12628036 | 2 | Hepatic cirrhosis |
| 126280361 | 12628036 | 3 | Chronic hepatitis C |
| 126280361 | 12628036 | 4 | Hepatic cirrhosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126280361 | 12628036 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126280361 | 12628036 | Alopecia | |
| 126280361 | 12628036 | Asthenia | |
| 126280361 | 12628036 | Blood bilirubin increased | |
| 126280361 | 12628036 | Chills | |
| 126280361 | 12628036 | Depression | |
| 126280361 | 12628036 | Dermatitis | |
| 126280361 | 12628036 | Diarrhoea | |
| 126280361 | 12628036 | Fatigue | |
| 126280361 | 12628036 | Haemoglobin decreased | |
| 126280361 | 12628036 | Headache | |
| 126280361 | 12628036 | Insomnia | |
| 126280361 | 12628036 | Irritability | |
| 126280361 | 12628036 | Lymphocyte count decreased | |
| 126280361 | 12628036 | Myalgia | |
| 126280361 | 12628036 | Nausea | |
| 126280361 | 12628036 | Neutrophil count decreased | |
| 126280361 | 12628036 | Platelet count decreased | |
| 126280361 | 12628036 | Pruritus | |
| 126280361 | 12628036 | Pyrexia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |