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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126214381 | 12621438 | 1 | I | 20160407 | 20160718 | 20160804 | 20160804 | EXP | DE-TEVA-678358GER | TEVA | 1.00 | DY | M | Y | 2.67000 | KG | 20160804 | CN | DE | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126214381 | 12621438 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | 50 MILLIGRAM DAILY; | 76465 | 50 | MG | QD | |||||||
| 126214381 | 12621438 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Transplacental | 0 | |||||||||||
| 126214381 | 12621438 | 3 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Transplacental | 10 MG PER DAY, IF REQUIRED | 0 | ||||||||||
| 126214381 | 12621438 | 4 | C | salbutamol | ALBUTEROL | 1 | Transplacental | 0.1 MG PER DAY, IF REQUIRED | 0 | ||||||||||
| 126214381 | 12621438 | 5 | C | PROTOPIC | TACROLIMUS | 1 | Transplacental | 0 | |||||||||||
| 126214381 | 12621438 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126214381 | 12621438 | 1 | Depression |
| 126214381 | 12621438 | 2 | Asthma |
| 126214381 | 12621438 | 3 | Food allergy |
| 126214381 | 12621438 | 4 | Asthma |
| 126214381 | 12621438 | 5 | Neurodermatitis |
| 126214381 | 12621438 | 6 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126214381 | 12621438 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126214381 | 12621438 | Foetal exposure during pregnancy | |
| 126214381 | 12621438 | Small for dates baby |
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 |
|---|---|---|---|---|---|---|
| 126214381 | 12621438 | 1 | 20150709 | 20160407 | 0 | |
| 126214381 | 12621438 | 2 | 20150709 | 20160407 | 0 | |
| 126214381 | 12621438 | 3 | 20150709 | 20160407 | 0 | |
| 126214381 | 12621438 | 4 | 20150709 | 20160407 | 0 | |
| 126214381 | 12621438 | 5 | 20150709 | 20160407 | 0 | |
| 126214381 | 12621438 | 6 | 20150822 | 20160407 | 0 |