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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215712 | 12521571 | 2 | F | 20160515 | 20160720 | 20160701 | 20160802 | EXP | AU-NOVEN PHARMACEUTICALS, INC.-AU2016001656 | NOVEN | 0.00 | Y | 0.00000 | 20160802 | CN | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215712 | 12521571 | 1 | PS | Estradiol/Norethisterone Acetate | ESTRADIOLNORETHINDRONE ACETATE | 1 | Unknown | 1 DF(50/140 MCG), 2/WK | N | 979516 | 20870 | 1 | DF | TRANSDERMAL PATCH | BIW | ||||
| 125215712 | 12521571 | 2 | SS | Estradiol/Norethisterone Acetate | ESTRADIOLNORETHINDRONE ACETATE | 1 | Unknown | 1 DF (50/250MCG), 2/WK | N | 79669 | 20870 | 1 | DF | TRANSDERMAL PATCH | BIW | ||||
| 125215712 | 12521571 | 3 | SS | Estradiol/Norethisterone Acetate | ESTRADIOLNORETHINDRONE ACETATE | 1 | Unknown | 1 DF (50/140 MCG), UNKNOWN | N | 78997 | 20870 | 1 | DF | TRANSDERMAL PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125215712 | 12521571 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125215712 | 12521571 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125215712 | 12521571 | Abdominal pain | |
| 125215712 | 12521571 | Contusion | |
| 125215712 | 12521571 | Dyspnoea | |
| 125215712 | 12521571 | Haemorrhage | |
| 125215712 | 12521571 | Headache | |
| 125215712 | 12521571 | Joint swelling | |
| 125215712 | 12521571 | Palpitations | |
| 125215712 | 12521571 | Peripheral swelling | |
| 125215712 | 12521571 | Pruritus generalised | |
| 125215712 | 12521571 | Urticaria | |
| 125215712 | 12521571 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125215712 | 12521571 | 1 | 20160404 | 2016 | 0 | |
| 125215712 | 12521571 | 2 | 2016 | 2016 | 0 | |
| 125215712 | 12521571 | 3 | 2016 | 0 |