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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113880992 | 11388099 | 2 | F | 20160913 | 20150817 | 20160916 | EXP | JP-GLAXOSMITHKLINE-JP2015JPN117549 | GLAXOSMITHKLINE | 0.00 | N | Y | 1.50000 | KG | 20160916 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113880992 | 11388099 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Transplacental | 300 MG, 1D | U | 20241 | 300 | MG | TABLET | QD | |||||
| 113880992 | 11388099 | 2 | SS | BETAMETHASONE. | BETAMETHASONE | 1 | Transplacental | U | 0 | ||||||||||
| 113880992 | 11388099 | 3 | C | ZONISAMIDE. | ZONISAMIDE | 1 | 200 MG, 1D | 0 | 200 | MG | QD | ||||||||
| 113880992 | 11388099 | 4 | C | DIAZEPAM. | DIAZEPAM | 1 | 6 MG, PRN | 0 | 6 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113880992 | 11388099 | 1 | Epilepsy |
| 113880992 | 11388099 | 4 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113880992 | 11388099 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113880992 | 11388099 | Foetal exposure during pregnancy | |
| 113880992 | 11388099 | Low birth weight baby | |
| 113880992 | 11388099 | Premature baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |