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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126423042 | 12642304 | 2 | F | 20160728 | 20160812 | 20160810 | 20160815 | EXP | US-PFIZER INC-2016374315 | PFIZER | 1.00 | DY | M | Y | 3.70000 | KG | 20160815 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126423042 | 12642304 | 1 | PS | BLINDED NICOTINE | NICOTINE | 1 | Transplacental | 4-12 CARTRIDGES DAILY (10 MG PER CARTRIDGE, UNIT WAS 4 MG DELIVERED) | 20385 | ||||||||||
| 126423042 | 12642304 | 2 | SS | BLINDED NICOTINE | NICOTINE | 1 | Transplacental | 4-12 CARTRIDGES DAILY (10 MG PER CARTRIDGE, UNIT WAS 4 MG DELIVERED) | 20385 | ||||||||||
| 126423042 | 12642304 | 3 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Transplacental | 4-12 CARTRIDGES DAILY (10 MG PER CARTRIDGE, UNIT WAS 4 MG DELIVERED) | 20385 | ||||||||||
| 126423042 | 12642304 | 4 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Transplacental | 4-12 CARTRIDGES DAILY (10 MG PER CARTRIDGE, UNIT WAS 4 MG DELIVERED) | 20385 | ||||||||||
| 126423042 | 12642304 | 5 | SS | SUBUTEX | BUPRENORPHINE HYDROCHLORIDE | 1 | Transplacental | 16 MG, DAILY | 0 | 16 | MG | ||||||||
| 126423042 | 12642304 | 6 | C | LAMICTAL XR | LAMOTRIGINE | 1 | Transplacental | 500 MG, UNK | 0 | 500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126423042 | 12642304 | 1 | Smoking cessation therapy |
| 126423042 | 12642304 | 2 | Smoking cessation therapy |
| 126423042 | 12642304 | 3 | Smoking cessation therapy |
| 126423042 | 12642304 | 4 | Smoking cessation therapy |
| 126423042 | 12642304 | 5 | Drug dependence |
| 126423042 | 12642304 | 6 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126423042 | 12642304 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126423042 | 12642304 | Drug withdrawal syndrome neonatal | |
| 126423042 | 12642304 | Maternal exposure during pregnancy |
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 |
|---|---|---|---|---|---|---|
| 126423042 | 12642304 | 1 | 20160210 | 20160315 | 0 | |
| 126423042 | 12642304 | 2 | 20160210 | 20160315 | 0 | |
| 126423042 | 12642304 | 3 | 20160210 | 20160315 | 0 | |
| 126423042 | 12642304 | 4 | 20160210 | 20160315 | 0 |