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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110052413 | 11005241 | 3 | F | 20141106 | 20160824 | 20150409 | 20160824 | EXP | DE-BRISTOL-MYERS SQUIBB COMPANY-20657847 | BRISTOL MYERS SQUIBB | 41.00 | YR | F | Y | 92.00000 | KG | 20160824 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110052413 | 11005241 | 1 | PS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | 15 MG, QD | 21436 | 15 | MG | TABLET | QD | ||||||
| 110052413 | 11005241 | 2 | SS | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 225 MG, QD | 0 | 225 | MG | QD | |||||||
| 110052413 | 11005241 | 3 | SS | ATOSIL | PROMETHAZINE HYDROCHLORIDE | 1 | Oral | 25 MG, PRN | 0 | 25 | MG | ||||||||
| 110052413 | 11005241 | 4 | SS | ATOSIL | PROMETHAZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 110052413 | 11005241 | 5 | SS | ATOSIL | PROMETHAZINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110052413 | 11005241 | 1 | Depression |
| 110052413 | 11005241 | 2 | Depression |
| 110052413 | 11005241 | 3 | Restlessness |
| 110052413 | 11005241 | 4 | Anxiety |
| 110052413 | 11005241 | 5 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110052413 | 11005241 | HO |
| 110052413 | 11005241 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110052413 | 11005241 | Cardiovascular disorder | |
| 110052413 | 11005241 | Dehydration | |
| 110052413 | 11005241 | Haemorrhage | |
| 110052413 | 11005241 | Live birth | |
| 110052413 | 11005241 | Maternal exposure during pregnancy | |
| 110052413 | 11005241 | Off label use | |
| 110052413 | 11005241 | Umbilical cord around neck |
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 |
|---|---|---|---|---|---|---|
| 110052413 | 11005241 | 1 | 201302 | 0 | ||
| 110052413 | 11005241 | 2 | 201302 | 0 | ||
| 110052413 | 11005241 | 3 | 201302 | 0 |