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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125468582 | 12546858 | 2 | F | 20160609 | 20160810 | 20160711 | 20160812 | EXP | FR-009507513-1607FRA003466 | MERCK | 82.13 | YR | M | Y | 0.00000 | 20160812 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125468582 | 12546858 | 1 | PS | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Oral | 100 MG (1 DF), PER DAY | U | 21995 | 100 | MG | FILM-COATED TABLET | QD | |||||
| 125468582 | 12546858 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG, UNK | U | 0 | 160 | MG | |||||||
| 125468582 | 12546858 | 3 | SS | CASODEX | BICALUTAMIDE | 1 | Oral | 50 MG (1 DF), PER DAY | U | 0 | 50 | MG | COATED TABLET | QD | |||||
| 125468582 | 12546858 | 4 | SS | lactulose mylan | LACTULOSE | 1 | Oral | 2 DF, PER DAY | U | 0 | 2 | DF | QD | ||||||
| 125468582 | 12546858 | 5 | SS | OXYNORMORO | OXYCODONE | 1 | Oral | IF NEEDED | U | 0 | ORODISPERSIBLE TABLET | ||||||||
| 125468582 | 12546858 | 6 | SS | BISOPROLOL EG | BISOPROLOL | 1 | Oral | 1.25 MG, PER DAY | U | 0 | QD | ||||||||
| 125468582 | 12546858 | 7 | SS | nicorandil biogaran | NICORANDIL | 1 | Oral | 20 MG (1 DF), PER DAY | U | 0 | 20 | MG | TABLET | QD | |||||
| 125468582 | 12546858 | 8 | SS | KARDEGIC | ASPIRIN LYSINE | 1 | Oral | 75 MG (1 DF), PER DAY, IN SACHET | U | 0 | 75 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 125468582 | 12546858 | 9 | SS | DIFFU-K | POTASSIUM CHLORIDE | 1 | Oral | 1 DF, PER DAY | 10 | DF | U | 0 | 1 | DF | QD | ||||
| 125468582 | 12546858 | 10 | SS | esomeprazole EG | ESOMEPRAZOLE | 1 | Oral | 1 DF, PER DAY | U | 0 | 1 | DF | QD | ||||||
| 125468582 | 12546858 | 11 | SS | prednisone mylan | PREDNISONE | 1 | Oral | 1 MG, PER DAY | U | 0 | 1 | MG | QD | ||||||
| 125468582 | 12546858 | 12 | SS | pravastatin EG | PRAVASTATIN SODIUM | 1 | Oral | 20 MG (1 DF), PER DAY | U | 0 | 20 | MG | FILM-COATED TABLET | QD | |||||
| 125468582 | 12546858 | 13 | SS | DOLIPRANE | ACETAMINOPHEN | 1 | Oral | 1 G, IF NEEDED | U | U | 0 | 1 | G | ||||||
| 125468582 | 12546858 | 14 | SS | NORMACOL | KARAYA GUM | 1 | Rectal | IF NEEDED | U | U | 0 | ||||||||
| 125468582 | 12546858 | 15 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 10 MG, 2 PER DAY | U | U | 0 | 10 | MG | PROLONGED-RELEASE TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125468582 | 12546858 | 1 | Diabetes mellitus |
| 125468582 | 12546858 | 2 | Prostate cancer |
| 125468582 | 12546858 | 3 | Prostate cancer |
| 125468582 | 12546858 | 4 | Constipation |
| 125468582 | 12546858 | 5 | Pain |
| 125468582 | 12546858 | 6 | Hypertension |
| 125468582 | 12546858 | 7 | Angina unstable |
| 125468582 | 12546858 | 8 | Cardiovascular event prophylaxis |
| 125468582 | 12546858 | 9 | Hypokalaemia |
| 125468582 | 12546858 | 10 | Gastrooesophageal reflux disease |
| 125468582 | 12546858 | 11 | Product used for unknown indication |
| 125468582 | 12546858 | 12 | Hypercholesterolaemia |
| 125468582 | 12546858 | 13 | Pain |
| 125468582 | 12546858 | 14 | Constipation |
| 125468582 | 12546858 | 15 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125468582 | 12546858 | DE |
| 125468582 | 12546858 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125468582 | 12546858 | Hepatic function abnormal |
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 |
|---|---|---|---|---|---|---|
| 125468582 | 12546858 | 1 | 20160606 | 0 | ||
| 125468582 | 12546858 | 2 | 20160524 | 0 | ||
| 125468582 | 12546858 | 3 | 20160210 | 0 | ||
| 125468582 | 12546858 | 4 | 20160528 | 0 | ||
| 125468582 | 12546858 | 5 | 20160526 | 0 | ||
| 125468582 | 12546858 | 6 | 20151127 | 0 | ||
| 125468582 | 12546858 | 9 | 20160528 | 20160606 | 0 | |
| 125468582 | 12546858 | 10 | 20160606 | 0 | ||
| 125468582 | 12546858 | 11 | 20160606 | 0 | ||
| 125468582 | 12546858 | 12 | 20160606 | 0 | ||
| 125468582 | 12546858 | 14 | 20160507 | 0 | ||
| 125468582 | 12546858 | 15 | 20160526 | 0 |