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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113655325 | 11365532 | 5 | F | 20150729 | 20160623 | 20150811 | 20160705 | EXP | JP-GILEAD-2015-0166324 | GILEAD | 80.00 | YR | E | F | Y | 50.90000 | KG | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113655325 | 11365532 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 12800 | MG | Y | 204671 | 400 | MG | TABLET | QD | |||
| 113655325 | 11365532 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 600 MG, QD | 19200 | MG | Y | 0 | 600 | MG | TABLET | QD | |||
| 113655325 | 11365532 | 3 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 113655325 | 11365532 | 4 | C | AMLODIN | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 113655325 | 11365532 | 5 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 113655325 | 11365532 | 6 | C | OLOPATADINE | OLOPATADINE | 1 | Oral | 5 MG, UNK | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113655325 | 11365532 | 1 | Chronic hepatitis C |
| 113655325 | 11365532 | 2 | Chronic hepatitis C |
| 113655325 | 11365532 | 3 | Chronic hepatitis C |
| 113655325 | 11365532 | 4 | Hypertension |
| 113655325 | 11365532 | 5 | Gastrooesophageal reflux disease |
| 113655325 | 11365532 | 6 | Rhinitis allergic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113655325 | 11365532 | OT |
| 113655325 | 11365532 | LT |
| 113655325 | 11365532 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113655325 | 11365532 | Cerebral infarction | |
| 113655325 | 11365532 | Dehydration | |
| 113655325 | 11365532 | Drug ineffective | |
| 113655325 | 11365532 | Hepatitis C | |
| 113655325 | 11365532 | Hepatocellular carcinoma |
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 |
|---|---|---|---|---|---|---|
| 113655325 | 11365532 | 1 | 20150701 | 20150803 | 0 | |
| 113655325 | 11365532 | 2 | 20150701 | 20150803 | 0 | |
| 113655325 | 11365532 | 3 | 20150829 | 0 | ||
| 113655325 | 11365532 | 4 | 20150829 | 0 | ||
| 113655325 | 11365532 | 5 | 20150829 | 0 | ||
| 113655325 | 11365532 | 6 | 20150829 | 0 |