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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127068231 | 12706823 | 1 | I | 201608 | 20160825 | 20160901 | 20160901 | EXP | BE-GLAXOSMITHKLINE-BE2016GSK124911 | GLAXOSMITHKLINE | 0.00 | M | Y | 0.00000 | 20160901 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127068231 | 12706823 | 1 | SS | Combodart | DUTASTERIDETAMSULOSIN | 1 | UNK | U | 0 | ||||||||||
| 127068231 | 12706823 | 2 | PS | AVODART | DUTASTERIDE | 1 | UNK | 21319 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127068231 | 12706823 | 1 | Benign prostatic hyperplasia |
| 127068231 | 12706823 | 2 | Benign prostatic hyperplasia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127068231 | 12706823 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127068231 | 12706823 | Asthenia | |
| 127068231 | 12706823 | Cardiac failure | |
| 127068231 | 12706823 | Eye swelling | |
| 127068231 | 12706823 | Polyuria | |
| 127068231 | 12706823 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 127068231 | 12706823 | 1 | 201608 | 0 | ||
| 127068231 | 12706823 | 2 | 201608 | 0 |