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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126001752 | 12600175 | 2 | F | 20160711 | 20160908 | 20160727 | 20160915 | EXP | RO-KADMON PHARMACEUTICALS, LLC-KAD201607-002794 | KADMON | 65.20 | YR | F | Y | 0.00000 | 20160915 | CN | RO | RO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126001752 | 12600175 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | FILM-COATED TABLET | Y | 1054936 | 77456 | FILM-COATED TABLET | |||||||
| 126001752 | 12600175 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Y | 1054936 | 77456 | ||||||||||
| 126001752 | 12600175 | 3 | SS | Viekirax | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Oral | 1058724 | 0 | ||||||||||
| 126001752 | 12600175 | 4 | SS | Viekirax | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | 1058724 | 0 | |||||||||||
| 126001752 | 12600175 | 5 | SS | Exviera | DASABUVIR | 1 | Oral | 1059033 | 0 | ||||||||||
| 126001752 | 12600175 | 6 | SS | Exviera | DASABUVIR | 1 | 1059033 | 0 | |||||||||||
| 126001752 | 12600175 | 7 | C | Ramipril 10 mg | 2 | Oral | 0 | ||||||||||||
| 126001752 | 12600175 | 8 | C | HUMULIN R | INSULIN HUMAN | 1 | 0 | ||||||||||||
| 126001752 | 12600175 | 9 | C | LEVEMIR | INSULIN DETEMIR | 1 | 0 | ||||||||||||
| 126001752 | 12600175 | 10 | C | Miofilin | 2 | INFUSION | 0 | INFUSION | |||||||||||
| 126001752 | 12600175 | 11 | C | Glucose | DEXTROSE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126001752 | 12600175 | 1 | Hepatic cirrhosis |
| 126001752 | 12600175 | 2 | Hepatitis C |
| 126001752 | 12600175 | 3 | Hepatitis C |
| 126001752 | 12600175 | 4 | Hepatic cirrhosis |
| 126001752 | 12600175 | 5 | Hepatitis C |
| 126001752 | 12600175 | 6 | Hepatic cirrhosis |
| 126001752 | 12600175 | 7 | Hypertension |
| 126001752 | 12600175 | 8 | Diabetes mellitus |
| 126001752 | 12600175 | 9 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126001752 | 12600175 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126001752 | 12600175 | Asthenia | |
| 126001752 | 12600175 | Blood glucose increased | |
| 126001752 | 12600175 | Haematemesis | |
| 126001752 | 12600175 | Haemoglobin decreased | |
| 126001752 | 12600175 | Hypotension | |
| 126001752 | 12600175 | Melaena | |
| 126001752 | 12600175 | Nausea | |
| 126001752 | 12600175 | Posture abnormal | |
| 126001752 | 12600175 | Restlessness | |
| 126001752 | 12600175 | Syncope | |
| 126001752 | 12600175 | Tremor | |
| 126001752 | 12600175 | Upper gastrointestinal haemorrhage | |
| 126001752 | 12600175 | Varices oesophageal |
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 |
|---|---|---|---|---|---|---|
| 126001752 | 12600175 | 1 | 20160620 | 20160712 | 0 | |
| 126001752 | 12600175 | 3 | 20160620 | 0 | ||
| 126001752 | 12600175 | 5 | 20160620 | 0 | ||
| 126001752 | 12600175 | 7 | 2006 | 0 | ||
| 126001752 | 12600175 | 8 | 2004 | 0 | ||
| 126001752 | 12600175 | 9 | 2004 | 0 | ||
| 126001752 | 12600175 | 10 | 20160902 | 0 |