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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114122722 | 11412272 | 2 | F | 201409 | 20160823 | 20150824 | 20160831 | EXP | JP-JNJFOC-20150815428 | JANSSEN | MATSUNAGA H, HIGASHI K, IIDA M. A CASE OF TYPE C HEPATIC CIRRHOSIS WITH DECREASED RESERVE CAPACITY OF THE LIVER AND AGGRAVATED INFLAMMATION FINDINGS BEFORE AND AFTER THE TRIPLE-DRUG THERAPY WITH PEGINTERFERON, RIBAVIRIN AND SIMEPREVIR. 19-JUN-2015;149. | 68.95 | YR | E | F | Y | 68.00000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114122722 | 11412272 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 114122722 | 11412272 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 0 | 800 | MG | CAPSULE | BID | |||||||
| 114122722 | 11412272 | 3 | SS | PEGINTERFERON ALFA-2A | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 100-120 MG | 0 | INJECTION | |||||||||
| 114122722 | 11412272 | 4 | C | AMLODIPINE BESILATE | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114122722 | 11412272 | 1 | Chronic hepatitis C |
| 114122722 | 11412272 | 2 | Chronic hepatitis C |
| 114122722 | 11412272 | 3 | Chronic hepatitis C |
| 114122722 | 11412272 | 4 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114122722 | 11412272 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114122722 | 11412272 | Diverticulum | |
| 114122722 | 11412272 | Hepatic function abnormal | |
| 114122722 | 11412272 | Hepatitis C | |
| 114122722 | 11412272 | Hepatocellular carcinoma | |
| 114122722 | 11412272 | Large intestine polyp | |
| 114122722 | 11412272 | Platelet count decreased | |
| 114122722 | 11412272 | Varices oesophageal | |
| 114122722 | 11412272 | 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 |
|---|---|---|---|---|---|---|
| 114122722 | 11412272 | 1 | 20140218 | 20140513 | 0 | |
| 114122722 | 11412272 | 2 | 20140218 | 20140807 | 0 | |
| 114122722 | 11412272 | 3 | 20140218 | 20140729 | 0 |