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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125008236 | 12500823 | 6 | F | 2007 | 20160906 | 20160627 | 20160909 | EXP | BR-009507513-1604BRA018606 | MERCK | 43.00 | YR | F | Y | 52.00000 | KG | 20160909 | CN | NL | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125008236 | 12500823 | 1 | PS | IMPLANON | ETONOGESTREL | 1 | Subcutaneous | ON THE LEFT ARM | 523278/547234 | 21529 | IMPLANT | ||||||||
| 125008236 | 12500823 | 2 | SS | IMPLANON | ETONOGESTREL | 1 | Subdermal | UNK | 21529 | IMPLANT | |||||||||
| 125008236 | 12500823 | 3 | SS | IMPLANON | ETONOGESTREL | 1 | Subdermal | UNK | 21529 | IMPLANT | |||||||||
| 125008236 | 12500823 | 4 | SS | IMPLANON | ETONOGESTREL | 1 | Subdermal | UNK, IN LEFT ARM | 21529 | IMPLANT | |||||||||
| 125008236 | 12500823 | 5 | SS | GESTINOL | ETHINYL ESTRADIOLGESTODENE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 125008236 | 12500823 | 6 | SS | GESTINOL | ETHINYL ESTRADIOLGESTODENE | 1 | Oral | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125008236 | 12500823 | 1 | Premenstrual syndrome |
| 125008236 | 12500823 | 2 | Contraception |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125008236 | 12500823 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125008236 | 12500823 | Amenorrhoea | |
| 125008236 | 12500823 | Breast enlargement | |
| 125008236 | 12500823 | Complication associated with device | |
| 125008236 | 12500823 | Drug dose omission | |
| 125008236 | 12500823 | Haemorrhage | |
| 125008236 | 12500823 | Incorrect drug administration duration | |
| 125008236 | 12500823 | Irritability | |
| 125008236 | 12500823 | Malaise | |
| 125008236 | 12500823 | Menorrhagia | |
| 125008236 | 12500823 | Menstruation normal | |
| 125008236 | 12500823 | Migraine | |
| 125008236 | 12500823 | Nausea | |
| 125008236 | 12500823 | Overdose | |
| 125008236 | 12500823 | Premenstrual syndrome | |
| 125008236 | 12500823 | Product use issue | |
| 125008236 | 12500823 | Stress | |
| 125008236 | 12500823 | Therapeutic response unexpected | |
| 125008236 | 12500823 | Vitamin D 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 |
|---|---|---|---|---|---|---|
| 125008236 | 12500823 | 1 | 20160208 | 0 | ||
| 125008236 | 12500823 | 2 | 2013 | 20160208 | 0 | |
| 125008236 | 12500823 | 3 | 2010 | 20160208 | 0 | |
| 125008236 | 12500823 | 4 | 2007 | 2010 | 0 | |
| 125008236 | 12500823 | 5 | 20160525 | 2016 | 0 | |
| 125008236 | 12500823 | 6 | 201607 | 0 |