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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118696847 | 11869684 | 7 | F | 20151218 | 20160822 | 20151228 | 20160824 | EXP | IT-ROCHE-1684214 | ROCHE | 39.87 | YR | M | Y | 0.00000 | 20160824 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118696847 | 11869684 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Oral | 21511 | FILM-COATED TABLET | ||||||||||
| 118696847 | 11869684 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | BOTTLE (HDPE) - 28 TABLETS, | Y | 0 | FILM-COATED TABLET | ||||||||
| 118696847 | 11869684 | 3 | SS | DAKLINZA | DACLATASVIR | 1 | Oral | BLISTER PACK (PVC/PCTFE/AL) - 28 TABLETS, LATEST DOSE ON 12-JAN-2016 | 0 | FILM-COATED TABLET | |||||||||
| 118696847 | 11869684 | 4 | C | PROPRANOLOL HYDROCHLORIDE. | PROPRANOLOL HYDROCHLORIDE | 1 | Oral | 0 | 40 | MG | TABLET | ||||||||
| 118696847 | 11869684 | 5 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 0 | 15 | MG | TABLET | ||||||||
| 118696847 | 11869684 | 6 | C | DOMPERIDONE MALEATE | DOMPERIDONE MALEATE | 1 | 0 | ||||||||||||
| 118696847 | 11869684 | 7 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 6000 I.U. AXA/0.6 ML -10 PRE-FILLED SYRINGES CONTAINING 0.6 ML | 0 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118696847 | 11869684 | 1 | Hepatic cirrhosis |
| 118696847 | 11869684 | 2 | Hepatic cirrhosis |
| 118696847 | 11869684 | 3 | Hepatic cirrhosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118696847 | 11869684 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118696847 | 11869684 | Hepatic cancer | |
| 118696847 | 11869684 | Hepatic neoplasm | |
| 118696847 | 11869684 | Hepatic vein thrombosis | |
| 118696847 | 11869684 | Hepatocellular carcinoma |
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 |
|---|---|---|---|---|---|---|
| 118696847 | 11869684 | 1 | 20150729 | 20160112 | 0 | |
| 118696847 | 11869684 | 2 | 20150729 | 20160112 | 0 | |
| 118696847 | 11869684 | 3 | 20150729 | 20160112 | 0 |