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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126414302 | 12641430 | 2 | F | 20160817 | 20160810 | 20160826 | EXP | BR-SA-2016SA145003 | AVENTIS | 4.00 | MON | I | M | Y | 3.30000 | KG | 20160826 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126414302 | 12641430 | 1 | PS | LANTUS | INSULIN GLARGINE | 1 | Transplacental | TRAN | UNK | 21081 | |||||||||
| 126414302 | 12641430 | 2 | SS | LANTUS | INSULIN GLARGINE | 1 | Transplacental | TRAN | UNK | 21081 | |||||||||
| 126414302 | 12641430 | 3 | SS | LANTUS | INSULIN GLARGINE | 1 | Transmammary | UNK | 21081 | ||||||||||
| 126414302 | 12641430 | 4 | SS | LANTUS | INSULIN GLARGINE | 1 | Transmammary | UNK | 21081 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126414302 | 12641430 | 1 | Foetal exposure during pregnancy |
| 126414302 | 12641430 | 2 | Exposure during breast feeding |
| 126414302 | 12641430 | 3 | Foetal exposure during pregnancy |
| 126414302 | 12641430 | 4 | Exposure during breast feeding |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126414302 | 12641430 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126414302 | 12641430 | Arrhythmia neonatal | |
| 126414302 | 12641430 | Exposure during breast feeding | |
| 126414302 | 12641430 | Foetal exposure during pregnancy | |
| 126414302 | 12641430 | Malaise | |
| 126414302 | 12641430 | Premature baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |