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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120620613 | 12062061 | 3 | F | 20150823 | 20160816 | 20160210 | 20160822 | EXP | US-GILEAD-2016-0196161 | GILEAD | 37.00 | YR | A | M | Y | 78.00000 | KG | 20160822 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120620613 | 12062061 | 1 | PS | LEDIPASVIR/SOFOSBUVIR | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, UNK | Y | 205834 | 1 | DF | TABLET | ||||||
| 120620613 | 12062061 | 2 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Oral | UNK | Y | 0 | |||||||||
| 120620613 | 12062061 | 3 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Oral | 10 UNK, UNK | 0 | ||||||||||
| 120620613 | 12062061 | 4 | C | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 120620613 | 12062061 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0 | |||||||||||
| 120620613 | 12062061 | 6 | C | DEXTROMETHORPHAN | DEXTROMETHORPHAN | 1 | Unknown | 0 | |||||||||||
| 120620613 | 12062061 | 7 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 120620613 | 12062061 | 8 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 120620613 | 12062061 | 9 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 120620613 | 12062061 | 10 | C | PROTONIX /00661201/ | OMEPRAZOLE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120620613 | 12062061 | 1 | Chronic hepatitis C |
| 120620613 | 12062061 | 2 | Drug dependence |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120620613 | 12062061 | OT |
| 120620613 | 12062061 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120620613 | 12062061 | Drug dose omission | |
| 120620613 | 12062061 | Hallucination | |
| 120620613 | 12062061 | Malaise | |
| 120620613 | 12062061 | Mental disorder | |
| 120620613 | 12062061 | Substance-induced psychotic disorder |
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 |
|---|---|---|---|---|---|---|
| 120620613 | 12062061 | 1 | 201606 | 0 | ||
| 120620613 | 12062061 | 2 | 20150820 | 20150824 | 0 |