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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114187365 | 11418736 | 5 | F | 20150716 | 20160901 | 20150826 | 20160915 | EXP | US-PFIZER INC-2015270628 | PFIZER | 43.00 | YR | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114187365 | 11418736 | 1 | PS | IBRANCE | PALBOCICLIB | 1 | Oral | 125 MG, CYCLIC (ONCE DAILY WITH FOOD FOR 21CONSECUTIVE DAYS FOLLOWED BY 7 DAYS OFF ) | 207103 | 125 | MG | CAPSULE | |||||||
| 114187365 | 11418736 | 2 | SS | IBRANCE | PALBOCICLIB | 1 | Oral | 100 MG, UNK | 207103 | 100 | MG | CAPSULE | |||||||
| 114187365 | 11418736 | 3 | SS | IBRANCE | PALBOCICLIB | 1 | Oral | 100 MG, CYCLIC(100 MG, CYCLIC (3 WEEKS ON/1WEEK OFF) | 207103 | 100 | MG | CAPSULE | |||||||
| 114187365 | 11418736 | 4 | SS | NAPROSYN | NAPROXEN | 1 | 2 DF, 2X/DAY | U | 0 | 2 | DF | TABLET | BID | ||||||
| 114187365 | 11418736 | 5 | C | LETROZOLE. | LETROZOLE | 1 | Oral | 2.5 MG, DAILY | 0 | 2.5 | MG | TABLET | |||||||
| 114187365 | 11418736 | 6 | C | LETROZOLE. | LETROZOLE | 1 | 0 | TABLET | |||||||||||
| 114187365 | 11418736 | 7 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | 2 DF, 2X/DAY | 0 | 2 | DF | BID | ||||||||
| 114187365 | 11418736 | 8 | C | ALBUTEROL. | ALBUTEROL | 1 | UNK | 0 | |||||||||||
| 114187365 | 11418736 | 9 | C | BENZOATE CALCIUM | 2 | UNK | 0 | ||||||||||||
| 114187365 | 11418736 | 10 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 5000 IU, 1X/DAY | 0 | 5000 | IU | QD | |||||||
| 114187365 | 11418736 | 11 | C | DENOSUMAB | DENOSUMAB | 1 | Subcutaneous | 120 MG, MONTHLY | 0 | 120 | MG | /month | |||||||
| 114187365 | 11418736 | 12 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 100 MG, 3X/DAY | 0 | 100 | MG | CAPSULE | TID | ||||||
| 114187365 | 11418736 | 13 | C | MELATONIN | MELATONIN | 1 | Oral | 10 MG, AS NEEDED(AT NIGHT) | 0 | 10 | MG | TABLET | |||||||
| 114187365 | 11418736 | 14 | C | MORPHINE ER | MORPHINE | 1 | Oral | 30 MG, 2X/DAY | 0 | 30 | MG | PROLONGED-RELEASE TABLET | BID | ||||||
| 114187365 | 11418736 | 15 | C | MORPHINE ER | MORPHINE | 1 | UNK | 0 | PROLONGED-RELEASE TABLET | ||||||||||
| 114187365 | 11418736 | 16 | C | MORPHINE | MORPHINE | 1 | Oral | 15 MG, AS NEEDED (Q4H) | 0 | 15 | MG | TABLET | |||||||
| 114187365 | 11418736 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, 1X/DAY | 0 | 20 | MG | CAPSULE | QD | ||||||
| 114187365 | 11418736 | 18 | C | ONDANSETRON | ONDANSETRON | 1 | 8 MG, AS NEEDED(3X/DAY) | 0 | 8 | MG | TABLET | ||||||||
| 114187365 | 11418736 | 19 | C | POLYETHYLENE GLYCOL | POLYETHYLENE GLYCOLS | 1 | Oral | 17 G, 2X/DAY | 0 | 17 | G | BID | |||||||
| 114187365 | 11418736 | 20 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | 0 | |||||||||||
| 114187365 | 11418736 | 21 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | 2 DF, AS NEEDED(2 DF, AS NEEDED (90 MCG/ACT INHALER2 PUFF INH Q4H PRN) | 0 | 2 | DF | |||||||||
| 114187365 | 11418736 | 22 | C | BENZONATATE. | BENZONATATE | 1 | Oral | 200 MG, 3X/DAY | 0 | 200 | MG | CAPSULE | TID | ||||||
| 114187365 | 11418736 | 23 | C | BUDESONIDE W/FORMOTEROL FUMARATE | BUDESONIDEFORMOTEROL FUMARATE | 1 | Respiratory (inhalation) | 2 DF, 2X/DAY(2 DF, 2X/DAY (BUDESONIDE: 80 MCG/FORMOTEROL: 405 MCG)(2 PUFF INH BID) | 0 | 2 | DF | BID | |||||||
| 114187365 | 11418736 | 24 | C | CALCIUM | CALCIUM | 1 | Oral | 600 MG, 2X/DAY | 0 | 600 | MG | TABLET | BID | ||||||
| 114187365 | 11418736 | 25 | C | NAPROXEN SODIUM. | NAPROXEN SODIUM | 1 | Oral | 220 MG, DAILY | 0 | 220 | MG | TABLET | |||||||
| 114187365 | 11418736 | 26 | C | ORPHENADRINE CITRATE. | ORPHENADRINE CITRATE | 1 | Oral | 100 MG, 2X/DAY | 0 | 100 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114187365 | 11418736 | 1 | Breast cancer metastatic |
| 114187365 | 11418736 | 2 | Breast cancer stage IV |
| 114187365 | 11418736 | 5 | Breast cancer metastatic |
| 114187365 | 11418736 | 6 | Breast cancer stage IV |
| 114187365 | 11418736 | 14 | Breast cancer metastatic |
| 114187365 | 11418736 | 16 | Breast cancer metastatic |
| 114187365 | 11418736 | 18 | Nausea |
| 114187365 | 11418736 | 25 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114187365 | 11418736 | DE |
| 114187365 | 11418736 | OT |
| 114187365 | 11418736 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114187365 | 11418736 | Acute hepatic failure | |
| 114187365 | 11418736 | Breast cancer metastatic | |
| 114187365 | 11418736 | Condition aggravated | |
| 114187365 | 11418736 | Disease progression | |
| 114187365 | 11418736 | Disseminated intravascular coagulation | |
| 114187365 | 11418736 | Haemolysis | |
| 114187365 | 11418736 | Haemolytic anaemia | |
| 114187365 | 11418736 | Hepatitis | |
| 114187365 | 11418736 | International normalised ratio increased | |
| 114187365 | 11418736 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 114187365 | 11418736 | 1 | 20150321 | 0 | ||
| 114187365 | 11418736 | 2 | 20150430 | 20150716 | 0 | |
| 114187365 | 11418736 | 3 | 20150321 | 20150716 | 0 | |
| 114187365 | 11418736 | 4 | 20150716 | 0 | ||
| 114187365 | 11418736 | 5 | 20150321 | 20150716 | 0 | |
| 114187365 | 11418736 | 7 | 20150716 | 0 |