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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125893791 | 12589379 | 1 | I | 20160712 | 20160725 | 20160725 | EXP | KR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-47328BI | BOEHRINGER INGELHEIM | CHANG J,JANG H,HA CHUNG B,YOUN Y,SUNG I,KIM Y,ET AL. THE SUCCESSFUL CLINICAL OUTCOMES OF PREGNANT WOMEN WITH ADVANCED CHRONIC KIDNEY DISEASE. KIDNEY RESEARCH AND CLINICAL PRACTICE 2016;35:2:84-89. | 0.00 | N | Y | 1.46000 | KG | 20160725 | OT | COUNTRY NOT SPECIFIED | KR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125893791 | 12589379 | 1 | PS | MICARDIS | TELMISARTAN | 1 | Transplacental | 20850 | |||||||||||
| 125893791 | 12589379 | 2 | SS | NIFEDIPINE. | NIFEDIPINE | 1 | Transplacental | U | 0 | 30 | MG | ||||||||
| 125893791 | 12589379 | 3 | SS | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | 1 | Transplacental | 2.9000001 MCG/KG | U | 0 | |||||||||
| 125893791 | 12589379 | 4 | SS | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | 1 | Unknown | 2.4000001 MCG/KG | U | 0 | |||||||||
| 125893791 | 12589379 | 5 | SS | IRON | IRON | 1 | Transplacental | U | 0 | 270 | MG | ||||||||
| 125893791 | 12589379 | 6 | SS | IRON | IRON | 1 | Unknown | U | 0 | 190 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125893791 | 12589379 | 1 | Product used for unknown indication |
| 125893791 | 12589379 | 2 | Hypertension |
| 125893791 | 12589379 | 3 | Anaemia of pregnancy |
| 125893791 | 12589379 | 5 | Anaemia of pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125893791 | 12589379 | CA |
| 125893791 | 12589379 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125893791 | 12589379 | Bronchopulmonary dysplasia | |
| 125893791 | 12589379 | Congenital anomaly | |
| 125893791 | 12589379 | Foetal exposure during pregnancy | |
| 125893791 | 12589379 | Intraventricular haemorrhage | |
| 125893791 | 12589379 | Low birth weight baby | |
| 125893791 | 12589379 | Neonatal respiratory distress syndrome | |
| 125893791 | 12589379 | Premature baby | |
| 125893791 | 12589379 | Sepsis neonatal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |