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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199601 | 12619960 | 1 | I | 201407 | 20151030 | 20160803 | 20160803 | PER | US-ENDO PHARMACEUTICALS INC.-2015-003763 | ENDO | 51.64 | YR | M | Y | 95.34000 | KG | 20160803 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126199601 | 12619960 | 1 | PS | TESTOPEL | TESTOSTERONE | 1 | Unknown | 14 PELLETS INSERTED (1050 MG) | U | UNKNOWN | 80911 | 1050 | MG | IMPLANT | |||||
| 126199601 | 12619960 | 2 | SS | TESTOPEL | TESTOSTERONE | 1 | Unknown | 10 PELLETS INSERTED (750 MG) | U | UNKNOWN | 80911 | 750 | MG | IMPLANT | |||||
| 126199601 | 12619960 | 3 | SS | TESTOSTERONE. | TESTOSTERONE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126199601 | 12619960 | 4 | C | ERYTHROMYCIN. | ERYTHROMYCIN | 1 | 0 | ||||||||||||
| 126199601 | 12619960 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126199601 | 12619960 | 1 | Blood testosterone decreased |
| 126199601 | 12619960 | 3 | Blood testosterone decreased |
| 126199601 | 12619960 | 4 | Folliculitis |
| 126199601 | 12619960 | 5 | Vitamin D decreased |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126199601 | 12619960 | Chest pain | |
| 126199601 | 12619960 | Expulsion of medication | |
| 126199601 | 12619960 | Fatigue | |
| 126199601 | 12619960 | Implant site discolouration | |
| 126199601 | 12619960 | Malaise | |
| 126199601 | 12619960 | Mood swings | |
| 126199601 | 12619960 | Pain | |
| 126199601 | 12619960 | Pain in extremity | |
| 126199601 | 12619960 | Prescribed overdose | |
| 126199601 | 12619960 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 126199601 | 12619960 | 1 | 201407 | 201411 | 0 | |
| 126199601 | 12619960 | 2 | 201509 | 0 | ||
| 126199601 | 12619960 | 3 | 201509 | 0 |