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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 635009111 | 6350091 | 11 | F | 20070613 | 20160912 | 20070705 | 20160919 | EXP | JP-BRISTOL-MYERS SQUIBB COMPANY-13829551 | BRISTOL MYERS SQUIBB | 0.00 | DY | M | Y | 3.68000 | KG | 20160919 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 635009111 | 6350091 | 1 | PS | ABILIFY | ARIPIPRAZOLE | 1 | Transplacental | 12 MG, QD | 2307 | MG | D | 21436 | 12 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 2 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Transplacental | 24 MG, QD | 2307 | MG | D | 21436 | 24 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 3 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Transplacental | 9 MG, QD | 2307 | MG | D | 21436 | 9 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 4 | SS | DEPAS | ETIZOLAM | 1 | Transplacental | 2 MG, QD | 251 | MG | D | 0 | 2 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 5 | SS | DEPAS | ETIZOLAM | 1 | Transplacental | 1 MG, QD | 251 | MG | D | 0 | 1 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 6 | SS | DORAL | QUAZEPAM | 1 | Transplacental | 15 MG, QD | 45 | MG | D | 0 | 15 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 7 | SS | AKINETON | BIPERIDEN HYDROCHLORIDE | 1 | Transplacental | 2 MG, QD | 350 | MG | U | 0 | 2 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 8 | SS | AKINETON | BIPERIDEN HYDROCHLORIDE | 1 | Transplacental | 1.5 MG, QD | 350 | MG | U | 0 | 1.5 | MG | TABLET | QD | |||
| 635009111 | 6350091 | 9 | SS | SAWACILLIN | AMOXICILLIN | 1 | Transplacental | 250 MG, TID | U | 0 | 250 | MG | CAPSULE | TID | |||||
| 635009111 | 6350091 | 10 | SS | METHERGINE | METHYLERGONOVINE MALEATE | 1 | Transplacental | 0.125 MG, TID | U | 0 | .125 | MG | TID | ||||||
| 635009111 | 6350091 | 11 | SS | NEUER | CETRAXATE HYDROCHLORIDE | 1 | Transplacental | 200 MG, TID | U | 0 | 200 | MG | CAPSULE | TID | |||||
| 635009111 | 6350091 | 12 | SS | PENTCILLIN | PIPERACILLIN SODIUM | 1 | Transplacental | 1 G, QD | U | 0 | 1 | G | INJECTION | QD | |||||
| 635009111 | 6350091 | 13 | SS | ATONIN-O | OXYTOCIN | 1 | Transplacental | 5 IU, BID | U | 0 | 5 | IU | INJECTION | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 635009111 | 6350091 | 1 | Product used for unknown indication |
| 635009111 | 6350091 | 4 | Product used for unknown indication |
| 635009111 | 6350091 | 6 | Product used for unknown indication |
| 635009111 | 6350091 | 7 | Product used for unknown indication |
| 635009111 | 6350091 | 9 | Product used for unknown indication |
| 635009111 | 6350091 | 10 | Product used for unknown indication |
| 635009111 | 6350091 | 11 | Product used for unknown indication |
| 635009111 | 6350091 | 12 | Product used for unknown indication |
| 635009111 | 6350091 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 635009111 | 6350091 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 635009111 | 6350091 | Drug withdrawal syndrome neonatal | |
| 635009111 | 6350091 | Foetal exposure timing unspecified | |
| 635009111 | 6350091 | Infantile apnoea |
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 |
|---|---|---|---|---|---|---|
| 635009111 | 6350091 | 1 | 20061206 | 20061214 | 0 | |
| 635009111 | 6350091 | 2 | 20061215 | 20070121 | 0 | |
| 635009111 | 6350091 | 3 | 20070122 | 20070613 | 0 | |
| 635009111 | 6350091 | 4 | 20061206 | 20070204 | 0 | |
| 635009111 | 6350091 | 5 | 20070205 | 20070613 | 0 | |
| 635009111 | 6350091 | 6 | 20070611 | 20070613 | 0 | |
| 635009111 | 6350091 | 7 | 20061206 | 20070415 | 0 | |
| 635009111 | 6350091 | 8 | 20070416 | 20070613 | 0 | |
| 635009111 | 6350091 | 9 | 20070613 | 20070613 | 0 | |
| 635009111 | 6350091 | 10 | 20070613 | 20070613 | 0 | |
| 635009111 | 6350091 | 11 | 20070613 | 20070613 | 0 | |
| 635009111 | 6350091 | 12 | 20070613 | 20070613 | 0 | |
| 635009111 | 6350091 | 13 | 20070613 | 20070613 | 0 |