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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107105406 | 10710540 | 6 | F | 20140806 | 20160804 | 20150114 | 20160809 | EXP | JP-JNJFOC-20150106556 | JANSSEN | 74.49 | YR | E | M | Y | 61.00000 | KG | 20160809 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107105406 | 10710540 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 107105406 | 10710540 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 107105406 | 10710540 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 107105406 | 10710540 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 800 | MG | UNSPECIFIED | QD | ||||||
| 107105406 | 10710540 | 5 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 0 | 180 | UG | INJECTION | /wk | |||||||
| 107105406 | 10710540 | 6 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | QD | |||||||
| 107105406 | 10710540 | 7 | C | LOXOPROFEN | LOXOPROFEN | 1 | Oral | 0 | 60 | MG | UNSPECIFIED | ||||||||
| 107105406 | 10710540 | 8 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 107105406 | 10710540 | 9 | C | DEPAS | ETIZOLAM | 1 | Oral | 0 | 1 | MG | UNSPECIFIED | QD | |||||||
| 107105406 | 10710540 | 10 | C | TRAZENTA | LINAGLIPTIN | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107105406 | 10710540 | 1 | Chronic hepatitis C |
| 107105406 | 10710540 | 2 | Chronic hepatitis C |
| 107105406 | 10710540 | 3 | Chronic hepatitis C |
| 107105406 | 10710540 | 4 | Chronic hepatitis C |
| 107105406 | 10710540 | 5 | Chronic hepatitis C |
| 107105406 | 10710540 | 6 | Prophylaxis |
| 107105406 | 10710540 | 7 | Prophylaxis |
| 107105406 | 10710540 | 8 | Prophylaxis |
| 107105406 | 10710540 | 9 | Prophylaxis |
| 107105406 | 10710540 | 10 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107105406 | 10710540 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107105406 | 10710540 | Anaemia | |
| 107105406 | 10710540 | Diabetes mellitus | |
| 107105406 | 10710540 | Malaise | |
| 107105406 | 10710540 | Platelet count decreased | |
| 107105406 | 10710540 | Pleural effusion | |
| 107105406 | 10710540 | Pruritus | |
| 107105406 | 10710540 | Pyrexia | |
| 107105406 | 10710540 | Stomatitis | |
| 107105406 | 10710540 | Vomiting | |
| 107105406 | 10710540 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 107105406 | 10710540 | 1 | 20140806 | 20141028 | 0 | |
| 107105406 | 10710540 | 2 | 20150107 | 20150330 | 0 | |
| 107105406 | 10710540 | 3 | 20141224 | 20150106 | 0 | |
| 107105406 | 10710540 | 4 | 20140806 | 20141223 | 0 | |
| 107105406 | 10710540 | 5 | 20140806 | 20150225 | 0 | |
| 107105406 | 10710540 | 6 | 20140806 | 20150422 | 0 | |
| 107105406 | 10710540 | 7 | 20140806 | 20150303 | 0 | |
| 107105406 | 10710540 | 8 | 20140806 | 20150303 | 0 | |
| 107105406 | 10710540 | 9 | 20140806 | 20160713 | 0 | |
| 107105406 | 10710540 | 10 | 20141008 | 0 |