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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122538375 | 12253837 | 5 | F | 2015 | 20160721 | 20160411 | 20160728 | EXP | US-ABBVIE-16P-163-1601813-00 | ABBVIE | 0.00 | M | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122538375 | 12253837 | 1 | PS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNKNOWN FREQUENCY | U | UNKNOWN | 19010 | ||||||||
| 122538375 | 12253837 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | REGIMEN #1 | U | N | 1507016PCB,1507032PC,15016825PC,152 | 0 | 160 | MG | CAPSULE | QD | |||
| 122538375 | 12253837 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | REGIMEN #2 | U | N | 1507016PCB,1507032PC,15016825PC,152 | 0 | 80 | MG | CAPSULE | QD | |||
| 122538375 | 12253837 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | REGIMEN #3 | U | N | 1507016PCB,1507032PC,15016825PC,152 | 0 | 120 | MG | CAPSULE | QD | |||
| 122538375 | 12253837 | 5 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | REGIMEN #4 FREQUENCY UNKNOWN | U | N | 1507016PCB,1507032PC,15016825PC,152 | 0 | 120 | MG | CAPSULE | ||||
| 122538375 | 12253837 | 6 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | REGIMEN #5 | U | N | 1507016PCB,1507032PC,15016825PC,152 | 0 | 120 | MG | CAPSULE | QD | |||
| 122538375 | 12253837 | 7 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | N | 1507016PCB,1507032PC,15016825PC,152 | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122538375 | 12253837 | 1 | Product used for unknown indication |
| 122538375 | 12253837 | 2 | Prostate cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122538375 | 12253837 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122538375 | 12253837 | Abdominal discomfort | |
| 122538375 | 12253837 | Anxiety | |
| 122538375 | 12253837 | Asthenia | |
| 122538375 | 12253837 | Back pain | |
| 122538375 | 12253837 | Blood pressure increased | |
| 122538375 | 12253837 | Confusional state | |
| 122538375 | 12253837 | Diarrhoea | |
| 122538375 | 12253837 | Disorientation | |
| 122538375 | 12253837 | Dizziness | |
| 122538375 | 12253837 | Dry skin | |
| 122538375 | 12253837 | Dyspnoea | |
| 122538375 | 12253837 | Dysuria | |
| 122538375 | 12253837 | Fatigue | |
| 122538375 | 12253837 | Hair texture abnormal | |
| 122538375 | 12253837 | Headache | |
| 122538375 | 12253837 | Incorrect dose administered | |
| 122538375 | 12253837 | Insomnia | |
| 122538375 | 12253837 | Memory impairment | |
| 122538375 | 12253837 | Musculoskeletal stiffness | |
| 122538375 | 12253837 | Nephrostomy | |
| 122538375 | 12253837 | Paranasal sinus discomfort | |
| 122538375 | 12253837 | Rhinorrhoea | |
| 122538375 | 12253837 | Sinus congestion | |
| 122538375 | 12253837 | Sinusitis | |
| 122538375 | 12253837 | Vertigo | |
| 122538375 | 12253837 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 122538375 | 12253837 | 2 | 20150815 | 0 | ||
| 122538375 | 12253837 | 3 | 20150815 | 0 | ||
| 122538375 | 12253837 | 4 | 20150825 | 0 |