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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106947785 | 10694778 | 5 | F | 20140716 | 20160818 | 20150107 | 20160823 | EXP | JP-JNJFOC-20141220111 | JANSSEN | 67.73 | YR | E | M | Y | 63.00000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106947785 | 10694778 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 106947785 | 10694778 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 106947785 | 10694778 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 106947785 | 10694778 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 200 | MG | UNSPECIFIED | QD | ||||||
| 106947785 | 10694778 | 5 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 180 | UG | INJECTION | /wk | ||||||
| 106947785 | 10694778 | 6 | C | REZALTAS | AZELNIDIPINEOLMESARTAN MEDOXOMIL | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 106947785 | 10694778 | 7 | C | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Oral | 0 | 50 | MG | TABLET | QD | |||||||
| 106947785 | 10694778 | 8 | C | FLUITRAN | TRICHLORMETHIAZIDE | 1 | Oral | 0 | .5 | DF | TABLET | QD | |||||||
| 106947785 | 10694778 | 9 | C | ATORVASTATIN CA | 2 | Oral | 0 | 10 | MG | TABLET | QD | ||||||||
| 106947785 | 10694778 | 10 | C | YODEL | SENNA LEAF | 1 | Oral | 0 | 2 | DF | TABLET | QD | |||||||
| 106947785 | 10694778 | 11 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Oral | 0 | 300 | MG | TABLET | QD | |||||||
| 106947785 | 10694778 | 12 | C | TEPRENONE | TEPRENONE | 1 | Oral | 0 | 150 | MG | CAPSULE | QD | |||||||
| 106947785 | 10694778 | 13 | C | LOCHOL | FLUVASTATIN SODIUM | 1 | Oral | 0 | 200 | MG | TABLET | QD | |||||||
| 106947785 | 10694778 | 14 | C | LOXOPROFEN SODIUM | LOXOPROFEN SODIUM | 1 | Oral | 0 | 60 | MG | TABLET | QD | |||||||
| 106947785 | 10694778 | 15 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 0 | 100 | MG | TABLET | QD | |||||||
| 106947785 | 10694778 | 16 | C | POLAPREZINC | POLAPREZINC | 1 | Oral | 0 | 150 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106947785 | 10694778 | 1 | Chronic hepatitis C |
| 106947785 | 10694778 | 2 | Chronic hepatitis C |
| 106947785 | 10694778 | 3 | Chronic hepatitis C |
| 106947785 | 10694778 | 4 | Chronic hepatitis C |
| 106947785 | 10694778 | 5 | Chronic hepatitis C |
| 106947785 | 10694778 | 6 | Hypertension |
| 106947785 | 10694778 | 7 | Diabetes mellitus |
| 106947785 | 10694778 | 8 | Hypertension |
| 106947785 | 10694778 | 9 | Hyperlipidaemia |
| 106947785 | 10694778 | 10 | Constipation |
| 106947785 | 10694778 | 11 | Prophylaxis |
| 106947785 | 10694778 | 12 | Prophylaxis |
| 106947785 | 10694778 | 13 | Prophylaxis |
| 106947785 | 10694778 | 14 | Prophylaxis |
| 106947785 | 10694778 | 15 | Prophylaxis |
| 106947785 | 10694778 | 16 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106947785 | 10694778 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106947785 | 10694778 | Anaemia | |
| 106947785 | 10694778 | Hyperuricaemia | |
| 106947785 | 10694778 | Malaise | |
| 106947785 | 10694778 | Rash | |
| 106947785 | 10694778 | Renal impairment | |
| 106947785 | 10694778 | 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 |
|---|---|---|---|---|---|---|
| 106947785 | 10694778 | 1 | 20140709 | 20140930 | 0 | |
| 106947785 | 10694778 | 2 | 20140709 | 20140902 | 0 | |
| 106947785 | 10694778 | 3 | 20140903 | 20140917 | 0 | |
| 106947785 | 10694778 | 4 | 20141001 | 20141223 | 0 | |
| 106947785 | 10694778 | 5 | 20140709 | 20141217 | 0 | |
| 106947785 | 10694778 | 12 | 20140709 | 20140723 | 0 | |
| 106947785 | 10694778 | 13 | 20140709 | 20140723 | 0 | |
| 106947785 | 10694778 | 14 | 20140709 | 20140716 | 0 | |
| 106947785 | 10694778 | 15 | 20140709 | 20140716 | 0 | |
| 106947785 | 10694778 | 16 | 20141126 | 20141223 | 0 |