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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112017714 | 11201771 | 4 | F | 20141023 | 20160823 | 20150619 | 20160830 | EXP | JP-JNJFOC-20150610090 | JANSSEN | 62.93 | YR | A | M | Y | 56.00000 | KG | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112017714 | 11201771 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 112017714 | 11201771 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 112017714 | 11201771 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 112017714 | 11201771 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 800 | MG | UNSPECIFIED | QD | ||||||
| 112017714 | 11201771 | 5 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 112017714 | 11201771 | 6 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.43 | UG/KG | INJECTION | /wk | ||||||
| 112017714 | 11201771 | 7 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 112017714 | 11201771 | 8 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.43 | UG/KG | INJECTION | /wk | ||||||
| 112017714 | 11201771 | 9 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 112017714 | 11201771 | 10 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | Y | 0 | 1.5 | UG/KG | INJECTION | /wk | ||||||
| 112017714 | 11201771 | 11 | C | DEZOLAM | ETIZOLAM | 1 | Oral | 0 | .5 | MG | TABLET | ||||||||
| 112017714 | 11201771 | 12 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 0 | 300 | MG | TABLET | QD | |||||||
| 112017714 | 11201771 | 13 | C | AZILVA | AZILSARTAN KAMEDOXOMIL | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 112017714 | 11201771 | 14 | C | AZILVA | AZILSARTAN KAMEDOXOMIL | 1 | Oral | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112017714 | 11201771 | 1 | Chronic hepatitis C |
| 112017714 | 11201771 | 2 | Chronic hepatitis C |
| 112017714 | 11201771 | 3 | Chronic hepatitis C |
| 112017714 | 11201771 | 4 | Chronic hepatitis C |
| 112017714 | 11201771 | 5 | Chronic hepatitis C |
| 112017714 | 11201771 | 6 | Chronic hepatitis C |
| 112017714 | 11201771 | 7 | Chronic hepatitis C |
| 112017714 | 11201771 | 8 | Chronic hepatitis C |
| 112017714 | 11201771 | 9 | Chronic hepatitis C |
| 112017714 | 11201771 | 10 | Chronic hepatitis C |
| 112017714 | 11201771 | 11 | Insomnia |
| 112017714 | 11201771 | 12 | Prophylaxis |
| 112017714 | 11201771 | 13 | Hypertension |
| 112017714 | 11201771 | 14 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112017714 | 11201771 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112017714 | 11201771 | Anaemia | |
| 112017714 | 11201771 | Blood bilirubin increased | |
| 112017714 | 11201771 | Insomnia | |
| 112017714 | 11201771 | Oral herpes | |
| 112017714 | 11201771 | Pyrexia | |
| 112017714 | 11201771 | Rash |
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 |
|---|---|---|---|---|---|---|
| 112017714 | 11201771 | 1 | 20141021 | 20150112 | 0 | |
| 112017714 | 11201771 | 2 | 20141209 | 20150406 | 0 | |
| 112017714 | 11201771 | 3 | 20141104 | 20141208 | 0 | |
| 112017714 | 11201771 | 4 | 20141021 | 20141103 | 0 | |
| 112017714 | 11201771 | 5 | 20141021 | 20141021 | 0 | |
| 112017714 | 11201771 | 6 | 20141028 | 20141028 | 0 | |
| 112017714 | 11201771 | 7 | 20141104 | 20150331 | 0 | |
| 112017714 | 11201771 | 8 | 20141028 | 20141028 | 0 | |
| 112017714 | 11201771 | 9 | 20141021 | 20141021 | 0 | |
| 112017714 | 11201771 | 10 | 20141104 | 20150331 | 0 | |
| 112017714 | 11201771 | 11 | 20141023 | 20141029 | 0 | |
| 112017714 | 11201771 | 12 | 20141021 | 0 | ||
| 112017714 | 11201771 | 13 | 20141028 | 0 | ||
| 112017714 | 11201771 | 14 | 20141027 | 0 |