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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125471641 | 12547164 | 1 | I | 20151119 | 20160627 | 20160711 | 20160711 | EXP | DE-BFARM-16215414 | DE-FRI-1000085908 | FOREST | 0.00 | DY | F | Y | 2.22000 | KG | 20160711 | OT | DK | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125471641 | 12547164 | 1 | PS | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Transplacental | 10 MG | 21323 | 10 | MG | QD | |||||||
| 125471641 | 12547164 | 2 | SS | DECORTIN-H / PREDNISOLONE | PREDNISOLONE | 1 | Transplacental | 5.5 MG | 0 | 5.5 | MG | QD | |||||||
| 125471641 | 12547164 | 3 | SS | DECORTIN-H / PREDNISOLONE | PREDNISOLONE | 1 | Transplacental | 0 | 5 | MG | QD | ||||||||
| 125471641 | 12547164 | 4 | C | L-Thyroxin / Levothyroxine sodium | 2 | Transplacental | 75 MG | 0 | 75 | UG | QD | ||||||||
| 125471641 | 12547164 | 5 | C | Dekristol / Colecalciferol | 2 | Transplacental | 1000 IU | 0 | 1000 | IU | QD | ||||||||
| 125471641 | 12547164 | 6 | C | Dekristol / Colecalciferol | 2 | Transplacental | 0 | 500 | IU | QD | |||||||||
| 125471641 | 12547164 | 7 | C | Cytotec / Misoprostol | 2 | Transplacental | 0 | ||||||||||||
| 125471641 | 12547164 | 8 | C | Femibion Schwangerschaft 1 / Folic acid | 2 | Transplacental | 0.8 MG | 0 | .8 | MG | QD | ||||||||
| 125471641 | 12547164 | 9 | C | Ampicillin / Ampicillin | 2 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125471641 | 12547164 | 1 | Depression |
| 125471641 | 12547164 | 2 | Sarcoidosis |
| 125471641 | 12547164 | 4 | Hypothyroidism |
| 125471641 | 12547164 | 5 | Osteoporosis prophylaxis |
| 125471641 | 12547164 | 7 | Labour induction |
| 125471641 | 12547164 | 8 | Prophylaxis of neural tube defect |
| 125471641 | 12547164 | 9 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125471641 | 12547164 | CA |
| 125471641 | 12547164 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125471641 | 12547164 | Bradycardia neonatal | |
| 125471641 | 12547164 | Congenital hydronephrosis | |
| 125471641 | 12547164 | Foetal exposure during pregnancy | |
| 125471641 | 12547164 | Kidney duplex | |
| 125471641 | 12547164 | Respiratory disorder neonatal |
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 |
|---|---|---|---|---|---|---|
| 125471641 | 12547164 | 1 | 20150310 | 20151119 | 0 | |
| 125471641 | 12547164 | 2 | 20150310 | 20151119 | 0 | |
| 125471641 | 12547164 | 4 | 20150310 | 20151119 | 0 | |
| 125471641 | 12547164 | 5 | 20150310 | 20150413 | 0 | |
| 125471641 | 12547164 | 7 | 20151119 | 20151119 | 0 | |
| 125471641 | 12547164 | 9 | 20151119 | 20151119 | 0 |