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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124195963 | 12419596 | 3 | F | 20160418 | 20160809 | 20160531 | 20160816 | EXP | US-ASTELLAS-2016US015980 | ASTELLAS | 61.03 | YR | F | Y | 0.00000 | 20160816 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124195963 | 12419596 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 4640 | MG | 203415 | 160 | MG | CAPSULE | QD | |||||
| 124195963 | 12419596 | 2 | SS | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 6 | MG/KG | 0 | 6 | MG/KG | FORMULATION UNKNOWN | Q3W | |||||
| 124195963 | 12419596 | 3 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | UNK UNK, EVERY 6 HOURS | U | 0 | FORMULATION UNKNOWN | Q6H | |||||||
| 124195963 | 12419596 | 4 | C | BRILINTA | TICAGRELOR | 1 | Oral | U | 0 | 90 | MG | TABLET | Q12H | ||||||
| 124195963 | 12419596 | 5 | C | CALCIUM CARBONATE/VITAMIN D3 | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | 02 DF, ONCE DAILY | U | 0 | 2 | DF | TABLET | QD | |||||
| 124195963 | 12419596 | 6 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | U | 0 | 30 | MG | CAPSULE | QD | ||||||
| 124195963 | 12419596 | 7 | C | HEXAVITAMIN /00067501/ | 2 | Oral | 01 DF, ONCE DAILY | U | 0 | 1 | DF | TABLET | QD | ||||||
| 124195963 | 12419596 | 8 | C | HUMULIN NOS | INSULIN HUMAN | 1 | Subcutaneous | U | 0 | 100 | IU | FORMULATION UNKNOWN | BID | ||||||
| 124195963 | 12419596 | 9 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Oral | 4 MG, EVERY 04 HOUR AS NEEDED | U | 0 | 4 | MG | TABLET | ||||||
| 124195963 | 12419596 | 10 | C | Alevicyn | 2 | Topical | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | |||||||||
| 124195963 | 12419596 | 11 | C | FISH OIL | FISH OIL | 1 | Oral | 01 DF, ONCE DAILY | U | 0 | 1 | DF | CAPSULE | QD | |||||
| 124195963 | 12419596 | 12 | C | SENNOSIDE /00571901/ | SENNOSIDES A AND B | 1 | Oral | U | 0 | 2 | DF | TABLET | |||||||
| 124195963 | 12419596 | 13 | C | ASPIRIN. | ASPIRIN | 1 | Oral | U | 0 | 81 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124195963 | 12419596 | 14 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | U | 0 | 40 | MG | TABLET | QD | ||||||
| 124195963 | 12419596 | 15 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG, AS NEEDED ONCE DAILY | U | 0 | 20 | MG | TABLET | ||||||
| 124195963 | 12419596 | 16 | C | NEURONTIN | GABAPENTIN | 1 | Oral | U | 0 | 800 | MG | TABLET | TID | ||||||
| 124195963 | 12419596 | 17 | C | NEURONTIN | GABAPENTIN | 1 | Oral | U | 0 | 800 | MG | TABLET | BID | ||||||
| 124195963 | 12419596 | 18 | C | ORAMORPH | MORPHINE SULFATE | 1 | Oral | U | 0 | 60 | MG | TABLET | Q8H | ||||||
| 124195963 | 12419596 | 19 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 17 G, (DISSOLVED IN 8 OUNCES OF WATER) | U | 0 | 17 | G | FORMULATION UNKNOWN | ||||||
| 124195963 | 12419596 | 20 | C | K-DUR | POTASSIUM CHLORIDE | 1 | Oral | U | 0 | 10 | MEQ | TABLET | QD | ||||||
| 124195963 | 12419596 | 21 | C | ALTACE | RAMIPRIL | 1 | Oral | 05 MG, ONCE DAILY | U | 0 | 5 | MG | CAPSULE | QD | |||||
| 124195963 | 12419596 | 22 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124195963 | 12419596 | 1 | Breast cancer |
| 124195963 | 12419596 | 2 | Breast cancer |
| 124195963 | 12419596 | 3 | Product used for unknown indication |
| 124195963 | 12419596 | 4 | Product used for unknown indication |
| 124195963 | 12419596 | 5 | Product used for unknown indication |
| 124195963 | 12419596 | 6 | Neuralgia |
| 124195963 | 12419596 | 7 | Product used for unknown indication |
| 124195963 | 12419596 | 8 | Product used for unknown indication |
| 124195963 | 12419596 | 9 | Neuralgia |
| 124195963 | 12419596 | 10 | Product used for unknown indication |
| 124195963 | 12419596 | 11 | Product used for unknown indication |
| 124195963 | 12419596 | 12 | Product used for unknown indication |
| 124195963 | 12419596 | 13 | Product used for unknown indication |
| 124195963 | 12419596 | 14 | Product used for unknown indication |
| 124195963 | 12419596 | 15 | Product used for unknown indication |
| 124195963 | 12419596 | 16 | Neuralgia |
| 124195963 | 12419596 | 18 | Neuralgia |
| 124195963 | 12419596 | 19 | Product used for unknown indication |
| 124195963 | 12419596 | 20 | Product used for unknown indication |
| 124195963 | 12419596 | 21 | Product used for unknown indication |
| 124195963 | 12419596 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124195963 | 12419596 | DE |
| 124195963 | 12419596 | HO |
| 124195963 | 12419596 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124195963 | 12419596 | Asthenia | |
| 124195963 | 12419596 | Dyspnoea | |
| 124195963 | 12419596 | Malignant neoplasm progression | |
| 124195963 | 12419596 | Nausea | |
| 124195963 | 12419596 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124195963 | 12419596 | 1 | 20160316 | 20160413 | 0 | |
| 124195963 | 12419596 | 2 | 20160316 | 20160404 | 0 | |
| 124195963 | 12419596 | 4 | 20160404 | 0 | ||
| 124195963 | 12419596 | 5 | 20160404 | 0 | ||
| 124195963 | 12419596 | 7 | 20160404 | 0 | ||
| 124195963 | 12419596 | 8 | 20160403 | 0 | ||
| 124195963 | 12419596 | 10 | 20160404 | 0 |