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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113078018 | 11307801 | 8 | F | 20160919 | 20150724 | 20160929 | EXP | DE-ROCHE-1495718 | ROCHE | , PETERSEN J, HERZER K, FERENCI P, GSCHWANTLER M, WEDEMEYER H, BERG T, SPENGLER U, WEILAND O, VAN DER VALK M, ROCKSTROH J, PECK-RADOSAVLJEVIC M, ZHAO Y, JIMENEZ-EXPOSITO M AND ZEUZEM S. DACLATASVIR PLUS SOFOSBUVIR, WITH OR WITHOUT RIBAVIRIN, ACHIEVED HIGH SUSTAINED VIROLOGICAL RESPONSE RATES IN PATIENTS WITH HCV INFECTION AND ADVANCED LIVER DISEASE IN A REAL-WORLD COHORT. GUT 2016 SEP 07;:1-10. | 0.00 | Y | 0.00000 | 20160929 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113078018 | 11307801 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 21511 | |||||||||||
| 113078018 | 11307801 | 2 | SS | DACLATASVIR. | DACLATASVIR | 1 | Oral | 0 | |||||||||||
| 113078018 | 11307801 | 3 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | 0 | |||||||||||
| 113078018 | 11307801 | 4 | C | RITONAVIR. | RITONAVIR | 1 | Unknown | 0 | |||||||||||
| 113078018 | 11307801 | 5 | C | HIV PROTEINASE INHIBITOR | 2 | Unknown | 0 | ||||||||||||
| 113078018 | 11307801 | 6 | C | EFAVIRENZ | EFAVIRENZ | 1 | Unknown | 0 | |||||||||||
| 113078018 | 11307801 | 7 | C | NEVIRAPINE. | NEVIRAPINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113078018 | 11307801 | 1 | Chronic hepatitis C |
| 113078018 | 11307801 | 2 | Chronic hepatitis C |
| 113078018 | 11307801 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113078018 | 11307801 | DE |
| 113078018 | 11307801 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113078018 | 11307801 | Abdominal pain | |
| 113078018 | 11307801 | Acute kidney injury | |
| 113078018 | 11307801 | Anaemia | |
| 113078018 | 11307801 | Anal cancer | |
| 113078018 | 11307801 | Arthralgia | |
| 113078018 | 11307801 | Calculus urinary | |
| 113078018 | 11307801 | Circulatory collapse | |
| 113078018 | 11307801 | Clostridium difficile colitis | |
| 113078018 | 11307801 | Dehydration | |
| 113078018 | 11307801 | Diarrhoea | |
| 113078018 | 11307801 | Drug withdrawal syndrome | |
| 113078018 | 11307801 | Dyspnoea | |
| 113078018 | 11307801 | Erysipelas | |
| 113078018 | 11307801 | Fatigue | |
| 113078018 | 11307801 | Fluid overload | |
| 113078018 | 11307801 | Gastrointestinal infection | |
| 113078018 | 11307801 | General physical health deterioration | |
| 113078018 | 11307801 | Haemorrhoidal haemorrhage | |
| 113078018 | 11307801 | Headache | |
| 113078018 | 11307801 | Hepatic encephalopathy | |
| 113078018 | 11307801 | Hepatic failure | |
| 113078018 | 11307801 | Hepatocellular carcinoma | |
| 113078018 | 11307801 | Hypersensitivity vasculitis | |
| 113078018 | 11307801 | Hypertension | |
| 113078018 | 11307801 | Hyponatraemia | |
| 113078018 | 11307801 | Infection | |
| 113078018 | 11307801 | Lactic acidosis | |
| 113078018 | 11307801 | Liver disorder | |
| 113078018 | 11307801 | Lymphoedema | |
| 113078018 | 11307801 | Multiple organ dysfunction syndrome | |
| 113078018 | 11307801 | Myocardial infarction | |
| 113078018 | 11307801 | Nausea | |
| 113078018 | 11307801 | Neutropenia | |
| 113078018 | 11307801 | Pancreatitis acute | |
| 113078018 | 11307801 | Pancytopenia | |
| 113078018 | 11307801 | Peritonitis bacterial | |
| 113078018 | 11307801 | Portal vein thrombosis | |
| 113078018 | 11307801 | Soft tissue infection | |
| 113078018 | 11307801 | Somnolence | |
| 113078018 | 11307801 | Streptococcal sepsis | |
| 113078018 | 11307801 | Vertigo |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |