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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125760803 | 12576080 | 3 | F | 2016 | 20160816 | 20160720 | 20160819 | EXP | CN-GILEAD-2016-0208116 | GILEAD | 63.00 | YR | A | F | Y | 50.00000 | KG | 20160819 | MD | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125760803 | 12576080 | 1 | PS | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 1 | Oral | 300 MG, QD | A851221 | 21356 | 300 | MG | TABLET | QD | |||||
| 125760803 | 12576080 | 2 | SS | HEPTODIN | LAMIVUDINE | 1 | Oral | 100 MG, QD | 30000 | MG | 0 | 100 | MG | QD | |||||
| 125760803 | 12576080 | 3 | SS | ENTECAVIR. | ENTECAVIR | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125760803 | 12576080 | 1 | Hepatitis B |
| 125760803 | 12576080 | 2 | Hepatitis B |
| 125760803 | 12576080 | 3 | Hepatitis B |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125760803 | 12576080 | DE |
| 125760803 | 12576080 | HO |
| 125760803 | 12576080 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125760803 | 12576080 | Abdominal distension | |
| 125760803 | 12576080 | Asthenia | |
| 125760803 | 12576080 | Back pain | |
| 125760803 | 12576080 | Blood creatine phosphokinase increased | |
| 125760803 | 12576080 | Death | |
| 125760803 | 12576080 | Decreased appetite | |
| 125760803 | 12576080 | Drug resistance | |
| 125760803 | 12576080 | Face oedema | |
| 125760803 | 12576080 | Gastrointestinal haemorrhage | |
| 125760803 | 12576080 | Haematemesis | |
| 125760803 | 12576080 | Hepatic enzyme increased | |
| 125760803 | 12576080 | Jaundice | |
| 125760803 | 12576080 | Melaena | |
| 125760803 | 12576080 | Mental status changes | |
| 125760803 | 12576080 | Ocular icterus | |
| 125760803 | 12576080 | Pain | |
| 125760803 | 12576080 | Pain in extremity | |
| 125760803 | 12576080 | Suicidal ideation | |
| 125760803 | 12576080 | Vomiting | |
| 125760803 | 12576080 | Yellow skin |
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 |
|---|---|---|---|---|---|---|
| 125760803 | 12576080 | 1 | 201604 | 201606 | 0 | |
| 125760803 | 12576080 | 2 | 2014 | 201604 | 0 | |
| 125760803 | 12576080 | 3 | 201604 | 0 |