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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611501 | 12761150 | 1 | I | 20160908 | 20160920 | 20160920 | PER | PHEH2016US022899 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127611501 | 12761150 | 1 | PS | FEMARA | LETROZOLE | 1 | Oral | 1 DF, QD | U | 20726 | 1 | DF | TABLET | QD | |||||
| 127611501 | 12761150 | 2 | SS | PALBOCICLIB | PALBOCICLIB | 1 | Oral | 1 DF, PRN | U | 0 | 1 | DF | |||||||
| 127611501 | 12761150 | 3 | SS | XANAX | ALPRAZOLAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 127611501 | 12761150 | 4 | SS | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127611501 | 12761150 | 5 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127611501 | 12761150 | 6 | SS | DILANTIN | PHENYTOIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 127611501 | 12761150 | 7 | SS | FELDENE | PIROXICAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 127611501 | 12761150 | 8 | C | DULCOLAX NOS | BISACODYL OR DOCUSATE SODIUM | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | CAPSULE | BID | |||||
| 127611501 | 12761150 | 9 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | BID | |||||
| 127611501 | 12761150 | 10 | C | ASA | ASPIRIN | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 127611501 | 12761150 | 11 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 127611501 | 12761150 | 12 | C | LOVASTATIN. | LOVASTATIN | 1 | Oral | 1 DF, QHS | U | 0 | 1 | DF | TABLET | ||||||
| 127611501 | 12761150 | 13 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 127611501 | 12761150 | 14 | C | FISH OIL | FISH OIL | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 127611501 | 12761150 | 15 | C | ARIMIDEX | ANASTROZOLE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 127611501 | 12761150 | 16 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127611501 | 12761150 | 1 | Breast cancer metastatic |
| 127611501 | 12761150 | 2 | Product used for unknown indication |
| 127611501 | 12761150 | 3 | Product used for unknown indication |
| 127611501 | 12761150 | 4 | Product used for unknown indication |
| 127611501 | 12761150 | 5 | Product used for unknown indication |
| 127611501 | 12761150 | 6 | Product used for unknown indication |
| 127611501 | 12761150 | 7 | Product used for unknown indication |
| 127611501 | 12761150 | 8 | Faeces soft |
| 127611501 | 12761150 | 9 | Product used for unknown indication |
| 127611501 | 12761150 | 10 | Product used for unknown indication |
| 127611501 | 12761150 | 11 | Product used for unknown indication |
| 127611501 | 12761150 | 12 | Product used for unknown indication |
| 127611501 | 12761150 | 13 | Product used for unknown indication |
| 127611501 | 12761150 | 14 | Product used for unknown indication |
| 127611501 | 12761150 | 15 | Product used for unknown indication |
| 127611501 | 12761150 | 16 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127611501 | 12761150 | Back pain | |
| 127611501 | 12761150 | Breath sounds abnormal | |
| 127611501 | 12761150 | Confusional state | |
| 127611501 | 12761150 | Contusion | |
| 127611501 | 12761150 | Cough | |
| 127611501 | 12761150 | Drug hypersensitivity | |
| 127611501 | 12761150 | Dry mouth | |
| 127611501 | 12761150 | Dyspnoea | |
| 127611501 | 12761150 | Fatigue | |
| 127611501 | 12761150 | Headache | |
| 127611501 | 12761150 | Hyperhidrosis | |
| 127611501 | 12761150 | Musculoskeletal chest pain | |
| 127611501 | 12761150 | Nausea | |
| 127611501 | 12761150 | Pollakiuria | |
| 127611501 | 12761150 | Pruritus | |
| 127611501 | 12761150 | Rash | |
| 127611501 | 12761150 | Sleep disorder | |
| 127611501 | 12761150 | Thirst | |
| 127611501 | 12761150 | Tinnitus | |
| 127611501 | 12761150 | 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 |
|---|---|---|---|---|---|---|
| 127611501 | 12761150 | 1 | 20160629 | 0 | ||
| 127611501 | 12761150 | 2 | 20160718 | 0 | ||
| 127611501 | 12761150 | 15 | 20160629 | 0 |