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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126460201 | 12646020 | 1 | I | 20160629 | 20160808 | 20160811 | 20160811 | EXP | JP-ABBVIE-16P-087-1699692-00 | ABBVIE | 60.00 | YR | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126460201 | 12646020 | 1 | PS | TRICOR | FENOFIBRATE | 1 | Oral | Y | UNKNOWN | 21656 | 80 | MG | TABLET | QD | |||||
| 126460201 | 12646020 | 2 | C | AMLODIPINE BESILATE | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | QD | ||||||||
| 126460201 | 12646020 | 3 | C | EZETIMIBE. | EZETIMIBE | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 126460201 | 12646020 | 4 | C | CETIRIZINE HYDROCHLORIDE. | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126460201 | 12646020 | 1 | Hyperlipidaemia |
| 126460201 | 12646020 | 2 | Hypertension |
| 126460201 | 12646020 | 3 | Hyperlipidaemia |
| 126460201 | 12646020 | 4 | Rhinitis allergic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126460201 | 12646020 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126460201 | 12646020 | Alanine aminotransferase increased | |
| 126460201 | 12646020 | Aspartate aminotransferase increased | |
| 126460201 | 12646020 | Gamma-glutamyltransferase increased |
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 |
|---|---|---|---|---|---|---|
| 126460201 | 12646020 | 1 | 20160502 | 20160630 | 0 | |
| 126460201 | 12646020 | 2 | 201101 | 0 | ||
| 126460201 | 12646020 | 3 | 201301 | 20160630 | 0 | |
| 126460201 | 12646020 | 4 | 201508 | 0 |