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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125303622 | 12530362 | 2 | F | 20160705 | 20160706 | 20160718 | EXP | PL-AUROBINDO-AUR-APL-2016-08796 | AUROBINDO | 55.00 | YR | F | Y | 61.00000 | KG | 20160718 | MD | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125303622 | 12530362 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | 800 MG, UNK | 79111 | 800 | MG | |||||||||
| 125303622 | 12530362 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | 79111 | ||||||||||||
| 125303622 | 12530362 | 3 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Unknown | 80 MCG, EVERY WEEK | U | U | 0 | /wk | |||||||
| 125303622 | 12530362 | 4 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Unknown | 50 MCG, EVERY WEEK | U | U | 0 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125303622 | 12530362 | 1 | Hepatitis C |
| 125303622 | 12530362 | 2 | Chronic hepatitis C |
| 125303622 | 12530362 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125303622 | 12530362 | LT |
| 125303622 | 12530362 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125303622 | 12530362 | Alanine aminotransferase increased | |
| 125303622 | 12530362 | Anaemia | |
| 125303622 | 12530362 | Aspartate aminotransferase increased | |
| 125303622 | 12530362 | Asthenia | |
| 125303622 | 12530362 | Atrioventricular block | |
| 125303622 | 12530362 | Cough | |
| 125303622 | 12530362 | Electrocardiogram QT prolonged | |
| 125303622 | 12530362 | Generalised tonic-clonic seizure | |
| 125303622 | 12530362 | Loss of consciousness | |
| 125303622 | 12530362 | Oropharyngeal pain | |
| 125303622 | 12530362 | Palpitations | |
| 125303622 | 12530362 | Platelet count decreased | |
| 125303622 | 12530362 | Urinary incontinence | |
| 125303622 | 12530362 | Ventricular tachycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |