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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124092163 | 12409216 | 3 | F | 20160415 | 20160623 | 20160526 | 20160701 | EXP | IT-KADMON PHARMACEUTICALS, LLC-KAD201605-001938 | KADMON | 57.46 | YR | M | Y | 73.00000 | KG | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124092163 | 12409216 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 76203 | |||||||||||
| 124092163 | 12409216 | 2 | SS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | COATED TABLET | 0 | COATED TABLET | |||||||||
| 124092163 | 12409216 | 3 | C | Darunavir/Ritonavir | DARUNAVIRRITONAVIR | 1 | 0 | ||||||||||||
| 124092163 | 12409216 | 4 | C | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Oral | COATED TABLET | 0 | COATED TABLET | |||||||||
| 124092163 | 12409216 | 5 | C | Prezista 400 mg | 2 | Oral | COATED TABLET | 0 | COATED TABLET | ||||||||||
| 124092163 | 12409216 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124092163 | 12409216 | 1 | Hepatitis C |
| 124092163 | 12409216 | 2 | Hepatitis C |
| 124092163 | 12409216 | 3 | Antiretroviral therapy |
| 124092163 | 12409216 | 4 | HIV infection |
| 124092163 | 12409216 | 5 | HIV infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124092163 | 12409216 | DE |
| 124092163 | 12409216 | HO |
| 124092163 | 12409216 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124092163 | 12409216 | Ascites | |
| 124092163 | 12409216 | Cardiac arrest | |
| 124092163 | 12409216 | Disturbance in attention | |
| 124092163 | 12409216 | Gastric varices haemorrhage | |
| 124092163 | 12409216 | Haematemesis | |
| 124092163 | 12409216 | Hepatic cirrhosis | |
| 124092163 | 12409216 | Jaundice | |
| 124092163 | 12409216 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 124092163 | 12409216 | 1 | 20160405 | 0 | ||
| 124092163 | 12409216 | 2 | 20160405 | 0 | ||
| 124092163 | 12409216 | 3 | 201304 | 0 | ||
| 124092163 | 12409216 | 4 | 20130430 | 0 | ||
| 124092163 | 12409216 | 5 | 20130430 | 0 |