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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1039522510 | 10395225 | 10 | F | 201212 | 20160707 | 20140820 | 20160721 | EXP | FR-009507513-1406FRA001917 | MERCK | 52.00 | YR | F | Y | 0.00000 | 20160721 | CN | CA | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1039522510 | 10395225 | 1 | PS | VICTRELIS | BOCEPREVIR | 1 | Oral | 4 CAPSULES THREE TIMES A DAY, TOTAL DAILY DOSE: 12 CAPS, TO START AFTER 4 WEEKS OF BI THERAPY | Y | 202258 | 4 | DF | CAPSULE | TID | |||||
| 1039522510 | 10395225 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 5 TABS, QD (2 TABLETS IN THE MORNING AND 3 TABLETS IN THE EVENING) | Y | 0 | 5 | DF | TABLET | QD | |||||
| 1039522510 | 10395225 | 3 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 1 INJECTION, QW | Y | 0 | 1 | DF | /wk | ||||||
| 1039522510 | 10395225 | 4 | C | ASCORBIC ACID. | ASCORBIC ACID | 1 | Oral | 1 TABLET, IN THE MORNING | U | 0 | 1 | DF | TABLET | QD | |||||
| 1039522510 | 10395225 | 5 | C | TOCO | UNSPECIFIED INGREDIENT | 1 | Oral | 1 TAB, QAM | U | 0 | 1 | DF | TABLET | QD | |||||
| 1039522510 | 10395225 | 6 | C | DAFALGAN | ACETAMINOPHEN | 1 | Oral | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1039522510 | 10395225 | 1 | Hepatitis C |
| 1039522510 | 10395225 | 2 | Hepatitis C |
| 1039522510 | 10395225 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1039522510 | 10395225 | HO |
| 1039522510 | 10395225 | OT |
| 1039522510 | 10395225 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1039522510 | 10395225 | Asthenia | |
| 1039522510 | 10395225 | Depression | |
| 1039522510 | 10395225 | Disturbance in attention | |
| 1039522510 | 10395225 | Dry skin | |
| 1039522510 | 10395225 | Dysgeusia | |
| 1039522510 | 10395225 | Epistaxis | |
| 1039522510 | 10395225 | Fatigue | |
| 1039522510 | 10395225 | Haemorrhage | |
| 1039522510 | 10395225 | Hallucination | |
| 1039522510 | 10395225 | Headache | |
| 1039522510 | 10395225 | Heart rate increased | |
| 1039522510 | 10395225 | Hepatic cirrhosis | |
| 1039522510 | 10395225 | Hepatic steatosis | |
| 1039522510 | 10395225 | Hyperthermia | |
| 1039522510 | 10395225 | Hypothyroidism | |
| 1039522510 | 10395225 | Influenza | |
| 1039522510 | 10395225 | Insomnia | |
| 1039522510 | 10395225 | Irritability | |
| 1039522510 | 10395225 | Malaise | |
| 1039522510 | 10395225 | Memory impairment | |
| 1039522510 | 10395225 | Metrorrhagia | |
| 1039522510 | 10395225 | Muscle spasms | |
| 1039522510 | 10395225 | Neck pain | |
| 1039522510 | 10395225 | Neutropenia | |
| 1039522510 | 10395225 | Ophthalmic herpes zoster | |
| 1039522510 | 10395225 | Pain | |
| 1039522510 | 10395225 | Palpitations | |
| 1039522510 | 10395225 | Panic attack | |
| 1039522510 | 10395225 | Pelvic pain | |
| 1039522510 | 10395225 | Photophobia | |
| 1039522510 | 10395225 | Rash | |
| 1039522510 | 10395225 | Therapy non-responder | |
| 1039522510 | 10395225 | Thrombocytopenia | |
| 1039522510 | 10395225 | Urinary tract infection | |
| 1039522510 | 10395225 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 1039522510 | 10395225 | 1 | 20121221 | 20131025 | 0 | |
| 1039522510 | 10395225 | 2 | 20121123 | 20131025 | 0 | |
| 1039522510 | 10395225 | 3 | 20121123 | 20131025 | 0 |