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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127099042 | 12709904 | 2 | F | 20160908 | 20160902 | 20160912 | EXP | BR-GLAXOSMITHKLINE-BR2016GSK126037 | GLAXOSMITHKLINE | 0.00 | M | Y | 100.00000 | KG | 20160912 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127099042 | 12709904 | 1 | PS | AVODART | DUTASTERIDE | 1 | Oral | 1 UNK, QD | ZF2439 | 21319 | 1 | DF | CAPSULE | QD | |||||
| 127099042 | 12709904 | 2 | SS | AVODART | DUTASTERIDE | 1 | UNK | ZK0002 | 21319 | CAPSULE | |||||||||
| 127099042 | 12709904 | 3 | C | MICARDIS AMLO | AMLODIPINE BESYLATETELMISARTAN | 1 | Oral | 1 UNK, QD | U | 0 | 1 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127099042 | 12709904 | 1 | Benign prostatic hyperplasia |
| 127099042 | 12709904 | 3 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127099042 | 12709904 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127099042 | 12709904 | Drug ineffective | |
| 127099042 | 12709904 | Pollakiuria | |
| 127099042 | 12709904 | Product quality issue | |
| 127099042 | 12709904 | Urinary retention |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |