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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126003113 | 12600311 | 3 | F | 20151218 | 20160728 | 20160727 | 20160804 | EXP | MX-UCBSA-2016027655 | UCB | 18.51 | YR | F | Y | 55.00000 | KG | 20160804 | MD | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126003113 | 12600311 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 250 MG, 2X/DAY (BID) | UNK | 21035 | 250 | MG | FILM-COATED TABLET | BID | |||||
| 126003113 | 12600311 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 500 MG, 3X/DAY (TID) | 21035 | 500 | MG | FILM-COATED TABLET | TID | ||||||
| 126003113 | 12600311 | 3 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 1000 MG, 2X/DAY (BID) | 21035 | 1000 | MG | FILM-COATED TABLET | BID | ||||||
| 126003113 | 12600311 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 1500 MG, 2X/DAY (BID) | 21035 | 1500 | MG | FILM-COATED TABLET | BID | ||||||
| 126003113 | 12600311 | 5 | SS | KEPPRA | LEVETIRACETAM | 1 | 500 MG, 2X/DAY (BID) | 21035 | 500 | MG | FILM-COATED TABLET | BID | |||||||
| 126003113 | 12600311 | 6 | C | Multivitamins | VITAMINS | 1 | Oral | 1 DF, ONCE DAILY (QD) | U | 0 | 1 | DF | QD | ||||||
| 126003113 | 12600311 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 4 MG, ONCE DAILY (QD) | U | 0 | 4 | MG | QD | ||||||
| 126003113 | 12600311 | 8 | C | PHENYTOIN. | PHENYTOIN | 1 | Oral | 200 MG, 2X/DAY (BID) | U | 0 | 200 | MG | BID | ||||||
| 126003113 | 12600311 | 9 | C | PHENYTOIN. | PHENYTOIN | 1 | 300 MG, 3X/DAY (TID) | U | 0 | 300 | MG | TID | |||||||
| 126003113 | 12600311 | 10 | C | PHENYTOIN. | PHENYTOIN | 1 | 100 MG, 2X/DAY (BID) | U | 0 | 100 | MG | BID | |||||||
| 126003113 | 12600311 | 11 | C | Ampicillin | AMPICILLIN | 1 | Oral | 500 MG, 2X/DAY (BID) | 32000 | MG | U | 0 | 500 | MG | BID | ||||
| 126003113 | 12600311 | 12 | C | PHENYTOIN. | PHENYTOIN | 1 | Intravenous (not otherwise specified) | 880 MG | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126003113 | 12600311 | 1 | Epilepsy |
| 126003113 | 12600311 | 6 | Pregnancy |
| 126003113 | 12600311 | 7 | Pregnancy |
| 126003113 | 12600311 | 8 | Epilepsy |
| 126003113 | 12600311 | 11 | Urinary tract infection |
| 126003113 | 12600311 | 12 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126003113 | 12600311 | HO |
| 126003113 | 12600311 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126003113 | 12600311 | Abnormal labour | |
| 126003113 | 12600311 | Breast feeding | |
| 126003113 | 12600311 | Exposure during pregnancy | |
| 126003113 | 12600311 | Foetal distress syndrome | |
| 126003113 | 12600311 | Haematoma | |
| 126003113 | 12600311 | Off label use | |
| 126003113 | 12600311 | Seizure | |
| 126003113 | 12600311 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 126003113 | 12600311 | 1 | 20151218 | 20160115 | 0 | |
| 126003113 | 12600311 | 2 | 20160115 | 20160118 | 0 | |
| 126003113 | 12600311 | 3 | 20160118 | 201606 | 0 | |
| 126003113 | 12600311 | 4 | 201606 | 201606 | 0 | |
| 126003113 | 12600311 | 5 | 201606 | 0 | ||
| 126003113 | 12600311 | 7 | 20160118 | 0 | ||
| 126003113 | 12600311 | 8 | 2010 | 0 | ||
| 126003113 | 12600311 | 11 | 20151215 | 20160122 | 0 |