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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127505961 | 12750596 | 1 | I | 20160115 | 20160105 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US000484 | ASTELLAS | 78.93 | YR | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127505961 | 12750596 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 12480 | MG | U | 203415 | 160 | MG | CAPSULE | QD | ||||
| 127505961 | 12750596 | 2 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. (EVERY 3 MONTHS) | 0 | FORMULATION UNKNOWN | |||||||||
| 127505961 | 12750596 | 3 | SS | XGEVA | DENOSUMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127505961 | 12750596 | 4 | C | DOXAZOSIN MESYLATE. | DOXAZOSIN MESYLATE | 1 | Oral | U | 0 | 1 | MG | TABLET | BID | ||||||
| 127505961 | 12750596 | 5 | C | DILTZAC | DILTIAZEM HYDROCHLORIDE | 1 | Oral | U | 0 | 1 | DF | CAPSULE | QD | ||||||
| 127505961 | 12750596 | 6 | C | GLYBURIDE. | GLYBURIDE | 1 | Oral | U | 0 | 2.5 | MG | TABLET | QD | ||||||
| 127505961 | 12750596 | 7 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 1 DF, AS NEEDED (EVERY 4 HOURS) | U | 0 | 1 | DF | FORMULATION UNKNOWN | ||||||
| 127505961 | 12750596 | 8 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | U | 0 | 1 | DF | TABLET | |||||||
| 127505961 | 12750596 | 9 | C | DURAGESIC | FENTANYL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. (EVERY 72 HOURS) | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127505961 | 12750596 | 10 | C | XARELTO | RIVAROXABAN | 1 | Oral | U | 0 | 20 | MG | TABLET | QD | ||||||
| 127505961 | 12750596 | 11 | C | CASODEX | BICALUTAMIDE | 1 | Unknown | U | 0 | 1 | DF | TABLET | QD | ||||||
| 127505961 | 12750596 | 12 | C | QVAR | BECLOMETHASONE DIPROPIONATE | 1 | UNK UNK, (1 PUFF) TWICE DAILY | U | 0 | FORMULATION UNKNOWN | BID | ||||||||
| 127505961 | 12750596 | 13 | C | LASIX | FUROSEMIDE | 1 | Oral | U | 0 | 1 | DF | TABLET | QD | ||||||
| 127505961 | 12750596 | 14 | C | IPRATROPIUM/ALBUTEROL | ALBUTEROLIPRATROPIUM | 1 | Unknown | UNK UNK, AS NEEDED (1 NEBULIZED EVRY 6 HOURS AS NEEDED) | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127505961 | 12750596 | 15 | C | SILVADENE | SILVER SULFADIAZINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127505961 | 12750596 | 16 | C | OXYGEN. | OXYGEN | 1 | Nasal | U | 0 | 2 | L | FORMULATION UNKNOWN | |||||||
| 127505961 | 12750596 | 17 | C | ALLERGY RELIEF /00917501/ | 2 | Oral | U | 0 | 1 | DF | TABLET | QD | |||||||
| 127505961 | 12750596 | 18 | C | STOOL SOFTENER | DOCUSATE CALCIUM | 1 | Oral | U | 0 | 1 | DF | TABLET | QD | ||||||
| 127505961 | 12750596 | 19 | C | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | U | 0 | 1 | DF | CAPSULE | BID | ||||||
| 127505961 | 12750596 | 20 | C | CALCIUM + VITAMIN D3 | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | U | 0 | 1 | DF | TABLET | BID | ||||||
| 127505961 | 12750596 | 21 | C | PRAVACHOL | PRAVASTATIN SODIUM | 1 | Oral | U | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127505961 | 12750596 | 1 | Prostate cancer |
| 127505961 | 12750596 | 2 | Hormone-refractory prostate cancer |
| 127505961 | 12750596 | 3 | Hormone-refractory prostate cancer |
| 127505961 | 12750596 | 4 | Product used for unknown indication |
| 127505961 | 12750596 | 5 | Product used for unknown indication |
| 127505961 | 12750596 | 6 | Product used for unknown indication |
| 127505961 | 12750596 | 7 | Pain |
| 127505961 | 12750596 | 8 | Nausea |
| 127505961 | 12750596 | 9 | Product used for unknown indication |
| 127505961 | 12750596 | 10 | Product used for unknown indication |
| 127505961 | 12750596 | 11 | Product used for unknown indication |
| 127505961 | 12750596 | 12 | Product used for unknown indication |
| 127505961 | 12750596 | 13 | Product used for unknown indication |
| 127505961 | 12750596 | 14 | Product used for unknown indication |
| 127505961 | 12750596 | 15 | Wound |
| 127505961 | 12750596 | 16 | Product used for unknown indication |
| 127505961 | 12750596 | 17 | Product used for unknown indication |
| 127505961 | 12750596 | 18 | Product used for unknown indication |
| 127505961 | 12750596 | 19 | Product used for unknown indication |
| 127505961 | 12750596 | 20 | Product used for unknown indication |
| 127505961 | 12750596 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127505961 | 12750596 | HO |
| 127505961 | 12750596 | DE |
| 127505961 | 12750596 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127505961 | 12750596 | Back pain | |
| 127505961 | 12750596 | Clostridium difficile infection | |
| 127505961 | 12750596 | Constipation | |
| 127505961 | 12750596 | Decreased appetite | |
| 127505961 | 12750596 | Drug intolerance | |
| 127505961 | 12750596 | Dyspnoea | |
| 127505961 | 12750596 | Fatigue | |
| 127505961 | 12750596 | Malignant neoplasm progression | |
| 127505961 | 12750596 | Pneumonia | |
| 127505961 | 12750596 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127505961 | 12750596 | 1 | 20151029 | 20160114 | 0 | |
| 127505961 | 12750596 | 2 | 20150622 | 0 | ||
| 127505961 | 12750596 | 3 | 201507 | 0 |