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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114558524 | 11455852 | 4 | F | 1995 | 20160713 | 20150903 | 20160725 | EXP | US-BAYER-2015-413400 | BAYER | 64.00 | YR | A | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114558524 | 11455852 | 1 | PS | CLIMARA | ESTRADIOL | 1 | Transdermal | UNK | 150041 | 20375 | TRANSDERMAL PATCH | ||||||||
| 114558524 | 11455852 | 2 | SS | CLIMARA | ESTRADIOL | 1 | Transdermal | UNK | 160081 | 20375 | TRANSDERMAL PATCH | ||||||||
| 114558524 | 11455852 | 3 | SS | CLIMARA | ESTRADIOL | 1 | Transdermal | UNK | 150041 | 20375 | TRANSDERMAL PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114558524 | 11455852 | 1 | Hot flush |
| 114558524 | 11455852 | 2 | Migraine |
| 114558524 | 11455852 | 3 | Hot flush |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114558524 | 11455852 | HO |
| 114558524 | 11455852 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114558524 | 11455852 | Application site dryness | |
| 114558524 | 11455852 | Application site erosion | |
| 114558524 | 11455852 | Application site hypersensitivity | |
| 114558524 | 11455852 | Application site rash | |
| 114558524 | 11455852 | Application site reaction | |
| 114558524 | 11455852 | Application site vesicles | |
| 114558524 | 11455852 | Cataract | |
| 114558524 | 11455852 | Clostridium difficile infection | |
| 114558524 | 11455852 | Device adhesion issue | |
| 114558524 | 11455852 | Device issue | |
| 114558524 | 11455852 | Device use issue | |
| 114558524 | 11455852 | Drug dose omission | |
| 114558524 | 11455852 | Drug level decreased | |
| 114558524 | 11455852 | Headache | |
| 114558524 | 11455852 | Inappropriate schedule of drug administration | |
| 114558524 | 11455852 | Infection | |
| 114558524 | 11455852 | Migraine | |
| 114558524 | 11455852 | Oesophageal operation | |
| 114558524 | 11455852 | Off label use | |
| 114558524 | 11455852 | Pancreatic disorder | |
| 114558524 | 11455852 | Pancreatic fibrosis | |
| 114558524 | 11455852 | Pancreatic steatosis | |
| 114558524 | 11455852 | Pancreatitis relapsing | |
| 114558524 | 11455852 | Pre-existing condition improved | |
| 114558524 | 11455852 | Product adhesion issue | |
| 114558524 | 11455852 | Product formulation issue | |
| 114558524 | 11455852 | Product use issue | |
| 114558524 | 11455852 | Scar | |
| 114558524 | 11455852 | Therapeutic response unexpected | |
| 114558524 | 11455852 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 114558524 | 11455852 | 1 | 1989 | 0 | ||
| 114558524 | 11455852 | 3 | 20150723 | 0 |