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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118789743 | 11878974 | 3 | F | 20150918 | 20160926 | 20151230 | 20160930 | EXP | PHEH2015US026784 | NOVARTIS | 0.00 | DY | M | Y | 7.32000 | KG | 20160930 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118789743 | 11878974 | 1 | PS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Transplacental | MATERNAL DOSE: 180 MG, BID | D | 50791 | |||||||||
| 118789743 | 11878974 | 2 | SS | NO TREATMENT RECEIVED | UNSPECIFIED INGREDIENT | 1 | Unknown | D | 0 | ||||||||||
| 118789743 | 11878974 | 3 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Transplacental | MATERNAL DOSE: 650MG BID | D | 0 | |||||||||
| 118789743 | 11878974 | 4 | C | PRENATAL | VITAMINS | 1 | Transplacental | MATERNAL DOSE: 1 DF QD | D | 0 | |||||||||
| 118789743 | 11878974 | 5 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Transplacental | MATERNAL DOSE: 100 MG, QD | D | 0 | |||||||||
| 118789743 | 11878974 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Transplacental | MATERNAL DOSE: 2.5 MG QD | D | 0 | |||||||||
| 118789743 | 11878974 | 7 | C | TACROLIMUS. | TACROLIMUS | 1 | Transplacental | MATERNAL DOSE: 2 MG BID | D | 0 | |||||||||
| 118789743 | 11878974 | 8 | C | SENSIPAR | CINACALCET HYDROCHLORIDE | 1 | Transplacental | MATERNAL DOSE: 60 MG QD | D | 0 | |||||||||
| 118789743 | 11878974 | 9 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Transplacental | MATERNAL DOSE: 100 UG QD | D | 0 | |||||||||
| 118789743 | 11878974 | 10 | C | MAGNESIUM | MAGNESIUM | 1 | Transplacental | MATERNAL DOSE: 600 MG, BID | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118789743 | 11878974 | 1 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 2 | Product used for unknown indication |
| 118789743 | 11878974 | 3 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 4 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 5 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 6 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 7 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 8 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 9 | Foetal exposure during pregnancy |
| 118789743 | 11878974 | 10 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118789743 | 11878974 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118789743 | 11878974 | Croup infectious | |
| 118789743 | 11878974 | Dermatitis contact | |
| 118789743 | 11878974 | Foetal exposure during pregnancy | |
| 118789743 | 11878974 | Milk allergy | |
| 118789743 | 11878974 | Neonatal candida infection | |
| 118789743 | 11878974 | Premature baby | |
| 118789743 | 11878974 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 118789743 | 11878974 | 3 | 20150226 | 0 |