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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100275962 | 10027596 | 2 | F | 20130728 | 20160914 | 20140318 | 20160929 | EXP | ADR 22239631-005 | GB-ALKEM-000519 | ALKEM | 1.00 | HR | I | M | Y | 3.99000 | KG | 20160929 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100275962 | 10027596 | 1 | PS | QUETIAPINE/QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | 1 | Transplacental | 200 MG EACH EVENING | Y | 201504 | 200 | MG | QD | ||||||
| 100275962 | 10027596 | 2 | SS | ZYPREXA | OLANZAPINE | 1 | Transplacental | 10 MG EACH EVENING | U | 0 | 10 | MG | QD | ||||||
| 100275962 | 10027596 | 3 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Transplacental | Y | 0 | 10 | MG | ||||||||
| 100275962 | 10027596 | 4 | SS | ZOPICLONE | ZOPICLONE | 1 | Transplacental | 7.5 MG EACH EVENING | U | 0 | 7.5 | MG | QD | ||||||
| 100275962 | 10027596 | 5 | SS | DULOXETINE. | DULOXETINE | 1 | Transplacental | Y | 0 | 60 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100275962 | 10027596 | 1 | Product used for unknown indication |
| 100275962 | 10027596 | 2 | Schizoaffective disorder |
| 100275962 | 10027596 | 3 | Product used for unknown indication |
| 100275962 | 10027596 | 4 | Product used for unknown indication |
| 100275962 | 10027596 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100275962 | 10027596 | OT |
| 100275962 | 10027596 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100275962 | 10027596 | Cleft palate | |
| 100275962 | 10027596 | Exposure during breast feeding | |
| 100275962 | 10027596 | Foetal exposure during pregnancy | |
| 100275962 | 10027596 | High arched palate | |
| 100275962 | 10027596 | Maternal drugs affecting foetus | |
| 100275962 | 10027596 | Selective eating disorder |
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 |
|---|---|---|---|---|---|---|
| 100275962 | 10027596 | 2 | 20130425 | 20130425 | 0 | |
| 100275962 | 10027596 | 3 | 20121120 | 20130103 | 0 |