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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124970592 | 12497059 | 2 | F | 201511 | 20160913 | 20160624 | 20160920 | EXP | JP-GILEAD-2016-0207313AA | GILEAD | 59.00 | YR | A | F | Y | 35.40000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124970592 | 12497059 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 33200 | MG | 204671 | 400 | MG | TABLET | QD | ||||
| 124970592 | 12497059 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 200 MG, TID | 49800 | MG | 0 | 200 | MG | TABLET | TID | ||||
| 124970592 | 12497059 | 3 | C | PURSENNID /00142207/ | SENNOSIDES A AND B | 1 | Oral | 24 MG, QD | 0 | 24 | MG | TABLET | QD | ||||||
| 124970592 | 12497059 | 4 | C | PURSENNID /00142207/ | SENNOSIDES A AND B | 1 | Oral | 12 MG, PRN | 0 | 12 | MG | TABLET | |||||||
| 124970592 | 12497059 | 5 | C | SENNA | SENNA LEAFSENNOSIDESSENNOSIDES A AND B | 1 | Oral | 1 G, QD | 0 | 1 | G | GRANULES | QD | ||||||
| 124970592 | 12497059 | 6 | C | THYRADIN S | LEVOTHYROXINE SODIUM | 1 | Oral | 125 MG, QD | 0 | 125 | MG | TABLET | QD | ||||||
| 124970592 | 12497059 | 7 | C | THYRADIN S | LEVOTHYROXINE SODIUM | 1 | Oral | 100 MG, QD | 0 | 100 | MG | TABLET | QD | ||||||
| 124970592 | 12497059 | 8 | C | METLIGINE | MIDODRINE HYDROCHLORIDE | 1 | Oral | 2 MG, BID | 0 | 2 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124970592 | 12497059 | 1 | Chronic hepatitis C |
| 124970592 | 12497059 | 2 | Chronic hepatitis C |
| 124970592 | 12497059 | 3 | Constipation |
| 124970592 | 12497059 | 5 | Constipation |
| 124970592 | 12497059 | 6 | Hypothyroidism |
| 124970592 | 12497059 | 8 | Hypotension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124970592 | 12497059 | OT |
| 124970592 | 12497059 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124970592 | 12497059 | Anaemia | |
| 124970592 | 12497059 | Blood pressure decreased | |
| 124970592 | 12497059 | Bradycardia | |
| 124970592 | 12497059 | Decreased appetite | |
| 124970592 | 12497059 | Depression | |
| 124970592 | 12497059 | Enterocolitis | |
| 124970592 | 12497059 | Hypertonic bladder | |
| 124970592 | 12497059 | Malnutrition | |
| 124970592 | 12497059 | Oedema peripheral | |
| 124970592 | 12497059 | Pollakiuria |
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 |
|---|---|---|---|---|---|---|
| 124970592 | 12497059 | 1 | 20151007 | 20151229 | 0 | |
| 124970592 | 12497059 | 2 | 20151007 | 20151229 | 0 | |
| 124970592 | 12497059 | 3 | 20160222 | 0 | ||
| 124970592 | 12497059 | 4 | 20160222 | 0 | ||
| 124970592 | 12497059 | 5 | 20160222 | 0 | ||
| 124970592 | 12497059 | 6 | 20160308 | 0 | ||
| 124970592 | 12497059 | 7 | 20160309 | 0 |