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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125635153 | 12563515 | 3 | F | 2016 | 20160727 | 20160715 | 20160729 | EXP | US-GILEAD-2016-0222750 | GILEAD | 38.00 | YR | A | M | Y | 0.00000 | 20160729 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125635153 | 12563515 | 1 | PS | LEDIPASVIR/SOFOSBUVIR | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | 2 | DF | N | 601905 | 205834 | 1 | DF | TABLET | QD | ||
| 125635153 | 12563515 | 2 | SS | METHADONE | METHADONE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125635153 | 12563515 | 1 | Hepatitis C |
| 125635153 | 12563515 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125635153 | 12563515 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125635153 | 12563515 | Depression | |
| 125635153 | 12563515 | Hallucination | |
| 125635153 | 12563515 | Heart rate increased | |
| 125635153 | 12563515 | Negative thoughts | |
| 125635153 | 12563515 | Product distribution issue | |
| 125635153 | 12563515 | Product quality issue | |
| 125635153 | 12563515 | Weight 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 |
|---|---|---|---|---|---|---|
| 125635153 | 12563515 | 1 | 20160530 | 20160601 | 0 |