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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88211133 | 8821113 | 3 | F | 20101022 | 20160905 | 20121002 | 20160909 | EXP | JP-GLAXOSMITHKLINE-B0833967A | GLAXOSMITHKLINE | 9.05 | YR | M | Y | 27.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88211133 | 8821113 | 1 | PS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 20241 | TABLET | ||||||||||
| 88211133 | 8821113 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 20241 | 30 | MG | TABLET | ||||||||
| 88211133 | 8821113 | 3 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 20241 | 25 | MG | TABLET | ||||||||
| 88211133 | 8821113 | 4 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 20241 | 20 | MG | TABLET | ||||||||
| 88211133 | 8821113 | 5 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 20241 | 10 | MG | TABLET | ||||||||
| 88211133 | 8821113 | 6 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 125 MG, U | Y | 0 | 125 | MG | |||||||
| 88211133 | 8821113 | 7 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 250 MG, U | Y | 0 | 250 | MG | |||||||
| 88211133 | 8821113 | 8 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 500 MG, U | Y | 0 | 500 | MG | |||||||
| 88211133 | 8821113 | 9 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 750 MG, U | Y | 0 | 750 | MG | |||||||
| 88211133 | 8821113 | 10 | C | Mercazole | CARBIMAZOLE | 1 | Oral | U | 0 | 2 | MG | TABLET | QD | ||||||
| 88211133 | 8821113 | 11 | C | Excegran | ZONISAMIDE | 1 | Oral | U | 0 | 100 | MG | POWDER (EXCEPT [DPO]) | BID | ||||||
| 88211133 | 8821113 | 12 | C | Selenica-R | VALPROATE SODIUM | 1 | Oral | U | 0 | 350 | MG | GRANULES | BID | ||||||
| 88211133 | 8821113 | 13 | C | MYSTAN | CLOBAZAM | 1 | Oral | U | 0 | 4 | MG | ORAL POWDER | QD | ||||||
| 88211133 | 8821113 | 14 | C | MYSTAN | CLOBAZAM | 1 | Oral | U | 0 | 6 | MG | ORAL POWDER | |||||||
| 88211133 | 8821113 | 15 | C | MYSTAN | CLOBAZAM | 1 | Oral | U | 0 | 8 | MG | ORAL POWDER | |||||||
| 88211133 | 8821113 | 16 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 88211133 | 8821113 | 1 | Epilepsy |
| 88211133 | 8821113 | 10 | Hyperthyroidism |
| 88211133 | 8821113 | 11 | Epilepsy |
| 88211133 | 8821113 | 12 | Epilepsy |
| 88211133 | 8821113 | 13 | Epilepsy |
| 88211133 | 8821113 | 16 | Initial insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 88211133 | 8821113 | HO |
| 88211133 | 8821113 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 88211133 | 8821113 | Abasia | |
| 88211133 | 8821113 | Abnormal behaviour | |
| 88211133 | 8821113 | Asterixis | |
| 88211133 | 8821113 | Electroencephalogram abnormal | |
| 88211133 | 8821113 | Feeding disorder | |
| 88211133 | 8821113 | Gait disturbance | |
| 88211133 | 8821113 | Hypotonia | |
| 88211133 | 8821113 | Initial insomnia | |
| 88211133 | 8821113 | Lethargy | |
| 88211133 | 8821113 | Poor quality sleep | |
| 88211133 | 8821113 | Poverty of speech | |
| 88211133 | 8821113 | Sleep phase rhythm disturbance | |
| 88211133 | 8821113 | Somnolence | |
| 88211133 | 8821113 | Status epilepticus | |
| 88211133 | 8821113 | Tonic convulsion |
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 |
|---|---|---|---|---|---|---|
| 88211133 | 8821113 | 1 | 20100723 | 20101007 | 0 | |
| 88211133 | 8821113 | 2 | 20101008 | 20101226 | 0 | |
| 88211133 | 8821113 | 3 | 20101227 | 20110106 | 0 | |
| 88211133 | 8821113 | 4 | 20110107 | 0 |