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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119756163 | 11975616 | 3 | F | 20071109 | 20160907 | 20160129 | 20160914 | EXP | JP-BRISTOL-MYERS SQUIBB COMPANY-13918255 | BRISTOL MYERS SQUIBB | 0.00 | N | Y | 0.00000 | 20160914 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119756163 | 11975616 | 1 | PS | ABILIFY | ARIPIPRAZOLE | 1 | Transplacental | 3 MG, BID | 138 | MG | 21436 | 3 | MG | TABLET | BID | ||||
| 119756163 | 11975616 | 2 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Transplacental | 6 MG, BID | 138 | MG | 21436 | 6 | MG | TABLET | BID | ||||
| 119756163 | 11975616 | 3 | C | HIRNAMIN /00038601/ | LEVOMEPROMAZINE | 1 | Transplacental | 25 MG, QD | U | 0 | 25 | MG | TABLET | QD | |||||
| 119756163 | 11975616 | 4 | C | SORENTMIN /00774301/ | BROTIZOLAM | 1 | Transplacental | 0.25 MG, QD | U | 0 | .25 | MG | TABLET | QD | |||||
| 119756163 | 11975616 | 5 | C | LULLAN | PEROSPIRONE HYDROCHLORIDE | 1 | Transplacental | 4 MG, TID | 1352 | MG | U | 0 | 4 | MG | TABLET | TID | |||
| 119756163 | 11975616 | 6 | C | LULLAN | PEROSPIRONE HYDROCHLORIDE | 1 | Transplacental | 4 MG, QID | 1352 | MG | U | 0 | 4 | MG | TABLET | QID | |||
| 119756163 | 11975616 | 7 | C | LULLAN | PEROSPIRONE HYDROCHLORIDE | 1 | Transplacental | 4 MG, UNK | 1352 | MG | U | 0 | 4 | MG | TABLET | ||||
| 119756163 | 11975616 | 8 | C | LULLAN | PEROSPIRONE HYDROCHLORIDE | 1 | Transplacental | 4 MG, BID | 1352 | MG | U | 0 | 4 | MG | TABLET | BID | |||
| 119756163 | 11975616 | 9 | C | DEPAS | ETIZOLAM | 1 | Transplacental | UNK, PRN | U | 0 | |||||||||
| 119756163 | 11975616 | 10 | C | SOLANAX | ALPRAZOLAM | 1 | Transplacental | UNK, PRN | U | 0 | TABLET | ||||||||
| 119756163 | 11975616 | 11 | C | RIVOTRIL | CLONAZEPAM | 1 | Transplacental | UNK | U | 0 | |||||||||
| 119756163 | 11975616 | 12 | C | PHENPROBAMATE | PHENPROBAMATE | 1 | Transplacental | 200 MG, QD | 5800 | MG | U | 0 | 200 | MG | TABLET | QD | |||
| 119756163 | 11975616 | 13 | C | MIYA-BM | CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 | 1 | Transplacental | 80 MG, QD | 2320 | MG | U | 0 | 80 | MG | QD | ||||
| 119756163 | 11975616 | 14 | C | ACINON /00867001/ | 2 | Transplacental | 150 MG, QD | 750 | MG | U | 0 | 150 | MG | QD | |||||
| 119756163 | 11975616 | 15 | C | HERBAL EXTRACT NOS | HERBALS | 1 | Transplacental | UNK | U | 0 | ORAL POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119756163 | 11975616 | 1 | Product used for unknown indication |
| 119756163 | 11975616 | 3 | Product used for unknown indication |
| 119756163 | 11975616 | 4 | Product used for unknown indication |
| 119756163 | 11975616 | 5 | Product used for unknown indication |
| 119756163 | 11975616 | 9 | Product used for unknown indication |
| 119756163 | 11975616 | 10 | Product used for unknown indication |
| 119756163 | 11975616 | 11 | Product used for unknown indication |
| 119756163 | 11975616 | 12 | Product used for unknown indication |
| 119756163 | 11975616 | 13 | Product used for unknown indication |
| 119756163 | 11975616 | 14 | Product used for unknown indication |
| 119756163 | 11975616 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119756163 | 11975616 | CA |
| 119756163 | 11975616 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119756163 | 11975616 | Foetal exposure during pregnancy | |
| 119756163 | 11975616 | Large for dates baby | |
| 119756163 | 11975616 | Macrocephaly |
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 |
|---|---|---|---|---|---|---|
| 119756163 | 11975616 | 1 | 20070717 | 20070808 | 0 | |
| 119756163 | 11975616 | 2 | 20070809 | 20071109 | 0 | |
| 119756163 | 11975616 | 3 | 20070522 | 0 | ||
| 119756163 | 11975616 | 4 | 20070522 | 0 | ||
| 119756163 | 11975616 | 5 | 20070522 | 20070716 | 0 | |
| 119756163 | 11975616 | 6 | 20070717 | 20070730 | 0 | |
| 119756163 | 11975616 | 7 | 20070731 | 20070808 | 0 | |
| 119756163 | 11975616 | 8 | 20070809 | 20071004 | 0 | |
| 119756163 | 11975616 | 12 | 20070801 | 20070829 | 0 | |
| 119756163 | 11975616 | 13 | 20070801 | 20070829 | 0 | |
| 119756163 | 11975616 | 14 | 20070818 | 20070822 | 0 | |
| 119756163 | 11975616 | 15 | 20070619 | 20070828 | 0 |