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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126953701 | 12695370 | 1 | I | 20160803 | 20160829 | 20160829 | PER | US-BION-20160351 | BIONPHARMA | 37.00 | YR | A | F | Y | 110.68000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126953701 | 12695370 | 1 | PS | Progesterone Capsules | PROGESTERONE | 1 | Vaginal | 1 DF QD, VAGINAL | 200900 | 200 | MG | ||||||||
| 126953701 | 12695370 | 2 | SS | PROGESTERONE (SOLVAY PHARMA) | PROGESTERONE | 1 | Vaginal | 1 DF, QD VAGINAL | 0 | 200 | MG | ||||||||
| 126953701 | 12695370 | 3 | C | ESTRADIOL. | ESTRADIOL | 1 | 0 | 4 | MG | ||||||||||
| 126953701 | 12695370 | 4 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | 0 | ||||||||||||
| 126953701 | 12695370 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 126953701 | 12695370 | 6 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | 0 | ||||||||||||
| 126953701 | 12695370 | 7 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | 0 | 10 | MG | ||||||||||
| 126953701 | 12695370 | 8 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126953701 | 12695370 | 1 | Off label use |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126953701 | 12695370 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126953701 | 12695370 | Abortion spontaneous | |
| 126953701 | 12695370 | Emotional disorder | |
| 126953701 | 12695370 | Exposure during pregnancy | |
| 126953701 | 12695370 | Incorrect route of drug administration | |
| 126953701 | 12695370 | Product use issue | |
| 126953701 | 12695370 | Vaginal discharge |
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 |
|---|---|---|---|---|---|---|
| 126953701 | 12695370 | 1 | 20160730 | 0 |