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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126244001 | 12624400 | 1 | I | 201606 | 20160729 | 20160805 | 20160805 | EXP | US-ASTRAZENECA-2016SE82926 | ASTRAZENECA | 832.00 | MON | F | Y | 56.70000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126244001 | 12624400 | 1 | PS | FASLODEX | FULVESTRANT | 1 | Intramuscular | ONCE A MONTH INJECTED IN BUTTOCK | 21344 | INJECTION | |||||||||
| 126244001 | 12624400 | 2 | SS | IBRANCE | PALBOCICLIB | 1 | Oral | Y | U | M90851 | 0 | 125 | MG | CAPSULE | QD | ||||
| 126244001 | 12624400 | 3 | SS | IBRANCE | PALBOCICLIB | 1 | Oral | Y | U | M90851 | 0 | 125 | MG | CAPSULE | QD | ||||
| 126244001 | 12624400 | 4 | SS | IBRANCE | PALBOCICLIB | 1 | Oral | Y | U | M90851 | 0 | 125 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126244001 | 12624400 | 1 | Metastases to liver |
| 126244001 | 12624400 | 2 | Metastases to liver |
| 126244001 | 12624400 | 3 | Metastases to liver |
| 126244001 | 12624400 | 4 | Metastases to liver |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126244001 | 12624400 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126244001 | 12624400 | Asthenia | |
| 126244001 | 12624400 | Drug dose omission | |
| 126244001 | 12624400 | Feeling abnormal | |
| 126244001 | 12624400 | Hypersomnia | |
| 126244001 | 12624400 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 126244001 | 12624400 | 2 | 20160603 | 20160607 | 0 | |
| 126244001 | 12624400 | 3 | 20160623 | 0 | ||
| 126244001 | 12624400 | 4 | 20160627 | 20160630 | 0 |