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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127803701 | 12780370 | 1 | I | 20160401 | 20160920 | 20160926 | 20160926 | EXP | PHEH2016US024185 | NOVARTIS | 73.01 | YR | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127803701 | 12780370 | 1 | PS | FEMARA | LETROZOLE | 1 | Oral | 1 DF, QD | U | 20726 | 1 | DF | TABLET | QD | |||||
| 127803701 | 12780370 | 2 | SS | PALBOCICLIB | PALBOCICLIB | 1 | Oral | 125 MG, QD (ONCE A DAILY FOR 21 DAYS FOLLOWED BY A 7 DAY REST PERIOD TO COMPLETE A 28 DAYS CYCLE) | Y | 0 | 125 | MG | QD | ||||||
| 127803701 | 12780370 | 3 | SS | PALBOCICLIB | PALBOCICLIB | 1 | Oral | 75 MG, QD (ONCE A DAILY FOR 21 DAYS FOLLOWED BY A 7 DAY REST PERIOD TO COMPLETE A 28 DAYS CYCLE) | Y | 0 | 75 | MG | QD | ||||||
| 127803701 | 12780370 | 4 | C | ADVAIR DISKUS | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | (DOSE: 250 TO 50 MCG), PRN | U | 0 | |||||||||
| 127803701 | 12780370 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, QD (AD NEEDED) | U | 0 | 20 | MG | TABLET | QD | |||||
| 127803701 | 12780370 | 6 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 90 UG, PRN | U | 0 | 90 | UG | AEROSOL | ||||||
| 127803701 | 12780370 | 7 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | 25 MG, QD (AS NEEDED) | U | 0 | 25 | MG | TABLET | QD | |||||
| 127803701 | 12780370 | 8 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 5 MG/ML, PRN | U | 0 | SOLUTION | ||||||||
| 127803701 | 12780370 | 9 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Oral | 1 DF, QD (AS NEEDED) | U | 0 | 1 | DF | TABLET | QD | |||||
| 127803701 | 12780370 | 10 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | QD | |||||
| 127803701 | 12780370 | 11 | C | CALCIUM CITRATE | CALCIUM CITRATE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 127803701 | 12780370 | 12 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | QD | |||||
| 127803701 | 12780370 | 13 | C | DECADRON | DEXAMETHASONE | 1 | Oral | 12 MG, ONCE/SINGLE | D | 0 | 12 | MG | 1X | ||||||
| 127803701 | 12780370 | 14 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 16 MG, ONCE/SINGLE | D | 0 | 16 | MG | 1X | ||||||
| 127803701 | 12780370 | 15 | C | ATIVAN | LORAZEPAM | 1 | Oral | 0.5 MG, ONCE/SINGLE | D | 0 | .5 | MG | 1X | ||||||
| 127803701 | 12780370 | 16 | C | TRIAMCINOLONE ACETONIDE. | TRIAMCINOLONE ACETONIDE | 1 | Topical | (DOSE: 1 TOPICAL APPLICATION), BID | U | 0 | CREAM | BID | |||||||
| 127803701 | 12780370 | 17 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1060 MG, ONCE/SINGLE | D | 0 | 1060 | MG | 1X | ||||||
| 127803701 | 12780370 | 18 | C | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 100 MG, ONCE/SINGLE | D | 0 | 100 | MG | 1X | ||||||
| 127803701 | 12780370 | 19 | C | EMEND | APREPITANT | 1 | Intravenous (not otherwise specified) | 150 MG, ONCE/SINGLE | D | 0 | 150 | MG | 1X | ||||||
| 127803701 | 12780370 | 20 | C | NORMAL SALINE | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 250 ML, ONCE/SINGLE | D | 0 | 250 | ML | 1X | ||||||
| 127803701 | 12780370 | 21 | C | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, ONCE/SINGLE | D | 0 | 4 | MG | 1X | ||||||
| 127803701 | 12780370 | 22 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127803701 | 12780370 | 1 | Breast cancer metastatic |
| 127803701 | 12780370 | 2 | Breast cancer metastatic |
| 127803701 | 12780370 | 4 | Asthma |
| 127803701 | 12780370 | 5 | Asthma |
| 127803701 | 12780370 | 6 | Asthma |
| 127803701 | 12780370 | 7 | Product used for unknown indication |
| 127803701 | 12780370 | 8 | Asthma |
| 127803701 | 12780370 | 9 | Product used for unknown indication |
| 127803701 | 12780370 | 10 | Product used for unknown indication |
| 127803701 | 12780370 | 11 | Product used for unknown indication |
| 127803701 | 12780370 | 12 | Product used for unknown indication |
| 127803701 | 12780370 | 13 | Product used for unknown indication |
| 127803701 | 12780370 | 14 | Product used for unknown indication |
| 127803701 | 12780370 | 15 | Product used for unknown indication |
| 127803701 | 12780370 | 16 | Product used for unknown indication |
| 127803701 | 12780370 | 17 | Product used for unknown indication |
| 127803701 | 12780370 | 18 | Product used for unknown indication |
| 127803701 | 12780370 | 19 | Product used for unknown indication |
| 127803701 | 12780370 | 20 | Product used for unknown indication |
| 127803701 | 12780370 | 21 | Product used for unknown indication |
| 127803701 | 12780370 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127803701 | 12780370 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127803701 | 12780370 | Arthralgia | |
| 127803701 | 12780370 | Bone pain | |
| 127803701 | 12780370 | Fatigue | |
| 127803701 | 12780370 | Neutropenia | Neutropenia |
| 127803701 | 12780370 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 127803701 | 12780370 | 1 | 20151013 | 0 | ||
| 127803701 | 12780370 | 2 | 20151111 | 0 | ||
| 127803701 | 12780370 | 13 | 20150915 | 0 | ||
| 127803701 | 12780370 | 14 | 20150915 | 0 | ||
| 127803701 | 12780370 | 15 | 20150915 | 0 | ||
| 127803701 | 12780370 | 16 | 20150915 | 0 | ||
| 127803701 | 12780370 | 17 | 20150915 | 0 | ||
| 127803701 | 12780370 | 18 | 20150915 | 0 | ||
| 127803701 | 12780370 | 19 | 20150915 | 0 | ||
| 127803701 | 12780370 | 20 | 20151006 | 0 | ||
| 127803701 | 12780370 | 21 | 20151006 | 0 |