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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126784451 | 12678445 | 1 | I | 20160809 | 20160823 | 20160823 | PER | US-BAYER-2016-159568 | BAYER | 15.00 | YR | T | F | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126784451 | 12678445 | 1 | PS | OCELLA | DROSPIRENONEETHINYL ESTRADIOL | 1 | Oral | UNK | 21098 | FILM-COATED TABLET | |||||||||
| 126784451 | 12678445 | 2 | SS | OCELLA | DROSPIRENONEETHINYL ESTRADIOL | 1 | 21098 | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126784451 | 12678445 | 1 | Menstrual cycle management |
| 126784451 | 12678445 | 2 | Migraine |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126784451 | 12678445 | Abdominal pain | |
| 126784451 | 12678445 | Adverse event | |
| 126784451 | 12678445 | Constipation | |
| 126784451 | 12678445 | Impaired gastric emptying | |
| 126784451 | 12678445 | Nausea | |
| 126784451 | 12678445 | Off label use | |
| 126784451 | 12678445 | Pre-existing condition improved | |
| 126784451 | 12678445 | Vomiting | |
| 126784451 | 12678445 | 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 |
|---|---|---|---|---|---|---|
| 126784451 | 12678445 | 1 | 20160501 | 20160530 | 0 |