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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124922314 | 12492231 | 4 | F | 20160111 | 20160825 | 20160623 | 20160901 | EXP | US-ASTELLAS-2016US013992 | ASTELLAS | 56.44 | YR | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124922314 | 12492231 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | |||||||
| 124922314 | 12492231 | 2 | SS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | Y | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124922314 | 12492231 | 3 | SS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 203415 | 80 | MG | FORMULATION UNKNOWN | QD | |||||||
| 124922314 | 12492231 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 124922314 | 12492231 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 124922314 | 12492231 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 124922314 | 12492231 | 7 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 124922314 | 12492231 | 8 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 124922314 | 12492231 | 9 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 124922314 | 12492231 | 10 | C | OXYCODONE | OXYCODONE | 1 | Oral | 10 MG, EVERY 6 HOURS AS NEEDED | U | 0 | 10 | MG | TABLET | Q6H | |||||
| 124922314 | 12492231 | 11 | C | ATIVAN | LORAZEPAM | 1 | Oral | 1 MG, THRICE DAILY AS NEEDED (TAKE ON DAY OF CISPLATIN) | U | 0 | 1 | MG | TABLET | TID | |||||
| 124922314 | 12492231 | 12 | C | ATIVAN | LORAZEPAM | 1 | U | 0 | TABLET | ||||||||||
| 124922314 | 12492231 | 13 | C | MEGACE | MEGESTROL ACETATE | 1 | Oral | 40 MG/ML (800 MG, 20 ML), ONCE DAILY | U | 0 | FORMULATION UNKNOWN | QD | |||||||
| 124922314 | 12492231 | 14 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | Oral | U | 0 | 10 | MG | TABLET | TID | ||||||
| 124922314 | 12492231 | 15 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | U | 0 | TABLET | ||||||||||
| 124922314 | 12492231 | 16 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 8 MG, THRICE DAILY AS NEEDED (TAKE AROUND THE CLOCK) | U | 0 | 8 | MG | TABLET | TID | |||||
| 124922314 | 12492231 | 17 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 124922314 | 12492231 | 18 | C | MAGNESIUM GLUCONATE | MAGNESIUM GLUCONATE | 1 | Oral | U | 0 | 400 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124922314 | 12492231 | 19 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 4 MG, TWICE DAILY (TAKE ONE TABLET TWICE A DAY ON DAY 2,3,4,5,6) | U | 0 | 4 | MG | TABLET | BID | |||||
| 124922314 | 12492231 | 20 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | U | 0 | TABLET | ||||||||||
| 124922314 | 12492231 | 21 | C | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. (6 CYCLES) | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124922314 | 12492231 | 1 | Bladder transitional cell carcinoma |
| 124922314 | 12492231 | 4 | Product used for unknown indication |
| 124922314 | 12492231 | 10 | Pain |
| 124922314 | 12492231 | 11 | Nausea |
| 124922314 | 12492231 | 12 | Vomiting |
| 124922314 | 12492231 | 13 | Decreased appetite |
| 124922314 | 12492231 | 14 | Nausea |
| 124922314 | 12492231 | 15 | Vomiting |
| 124922314 | 12492231 | 16 | Nausea |
| 124922314 | 12492231 | 17 | Vomiting |
| 124922314 | 12492231 | 18 | Product used for unknown indication |
| 124922314 | 12492231 | 19 | Nausea |
| 124922314 | 12492231 | 20 | Vomiting |
| 124922314 | 12492231 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124922314 | 12492231 | HO |
| 124922314 | 12492231 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124922314 | 12492231 | Hyponatraemia | |
| 124922314 | 12492231 | Small intestinal obstruction |
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 |
|---|---|---|---|---|---|---|
| 124922314 | 12492231 | 1 | 20150831 | 201601 | 0 | |
| 124922314 | 12492231 | 2 | 20160111 | 20160131 | 0 | |
| 124922314 | 12492231 | 3 | 20160201 | 20160425 | 0 | |
| 124922314 | 12492231 | 4 | 20150831 | 0 | ||
| 124922314 | 12492231 | 5 | 20150921 | 0 | ||
| 124922314 | 12492231 | 6 | 20151012 | 0 | ||
| 124922314 | 12492231 | 7 | 20151109 | 0 | ||
| 124922314 | 12492231 | 8 | 20151130 | 0 | ||
| 124922314 | 12492231 | 9 | 20151221 | 0 | ||
| 124922314 | 12492231 | 21 | 20150831 | 20160120 | 0 |