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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126173611 | 12617361 | 1 | I | 20121212 | 20160720 | 20160803 | 20160803 | EXP | GB-AUROBINDO-AUR-APL-2016-09699 | AUROBINDO | 57.00 | YR | F | Y | 0.00000 | 20160803 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126173611 | 12617361 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 1200 MG, UNK | Y | U | 79111 | 1200 | MG | ||||||
| 126173611 | 12617361 | 2 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 150 ?G, EVERY WEEK | 42.8569984 | UG | Y | U | 0 | 150 | UG | /wk | |||
| 126173611 | 12617361 | 3 | SS | TELAPREVIR | TELAPREVIR | 1 | Oral | 2250 MG, UNK | Y | U | 0 | 2250 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126173611 | 12617361 | 1 | Chronic hepatitis C |
| 126173611 | 12617361 | 2 | Chronic hepatitis C |
| 126173611 | 12617361 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126173611 | 12617361 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126173611 | 12617361 | Anaemia | |
| 126173611 | 12617361 | Arthralgia | |
| 126173611 | 12617361 | Depressed mood | |
| 126173611 | 12617361 | Dry mouth | |
| 126173611 | 12617361 | Dyspnoea | |
| 126173611 | 12617361 | Eye swelling | |
| 126173611 | 12617361 | Fatigue | |
| 126173611 | 12617361 | Gingival bleeding | |
| 126173611 | 12617361 | Influenza like illness | |
| 126173611 | 12617361 | Mouth ulceration | |
| 126173611 | 12617361 | Nausea | |
| 126173611 | 12617361 | Neutropenia | |
| 126173611 | 12617361 | Pruritus | |
| 126173611 | 12617361 | Rash erythematous |
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 |
|---|---|---|---|---|---|---|
| 126173611 | 12617361 | 1 | 20121210 | 20130606 | 0 | |
| 126173611 | 12617361 | 2 | 20121210 | 20130603 | 0 | |
| 126173611 | 12617361 | 3 | 20121210 | 20130301 | 0 |