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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115856523 | 11585652 | 3 | F | 20130501 | 20160919 | 20151001 | 20160927 | EXP | US-ENDO PHARMACEUTICALS INC.-2015-002519 | ENDO | 51.21 | YR | M | Y | 122.58000 | KG | 20160927 | LW | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115856523 | 11585652 | 1 | PS | TESTIM | TESTOSTERONE | 1 | Transdermal | PER MEDICAL RECORDS '15 MG, ONE PACKET PER DAY' | 21454 | GEL | QD | ||||||||
| 115856523 | 11585652 | 2 | SS | TESTOSTERONE CYPIONATE. | TESTOSTERONE CYPIONATE | 1 | Unknown | U | 0 | INJECTION | QOW | ||||||||
| 115856523 | 11585652 | 3 | SS | ANDROGEL | TESTOSTERONE | 1 | Unknown | U | 0 | GEL | QD | ||||||||
| 115856523 | 11585652 | 4 | SS | ANDROGEL | TESTOSTERONE | 1 | Unknown | U | 0 | GEL | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115856523 | 11585652 | 1 | Androgen replacement therapy |
| 115856523 | 11585652 | 2 | Androgen replacement therapy |
| 115856523 | 11585652 | 3 | Androgen replacement therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115856523 | 11585652 | DS |
| 115856523 | 11585652 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115856523 | 11585652 | Cardiac tamponade | |
| 115856523 | 11585652 | Deep vein thrombosis | |
| 115856523 | 11585652 | Pericardial effusion | |
| 115856523 | 11585652 | Pulmonary embolism | |
| 115856523 | 11585652 | Weight 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 |
|---|---|---|---|---|---|---|
| 115856523 | 11585652 | 1 | 201106 | 201403 | 0 | |
| 115856523 | 11585652 | 2 | 200709 | 201009 | 0 | |
| 115856523 | 11585652 | 3 | 200611 | 0 | ||
| 115856523 | 11585652 | 4 | 200901 | 200903 | 0 |