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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122367222 | 12236722 | 2 | F | 201412 | 20160726 | 20160405 | 20160801 | EXP | FR-UCBSA-2016011684 | UCB | 75.33 | YR | M | Y | 0.00000 | 20160802 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122367222 | 12236722 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 1000 MG, 2X/DAY (BID); (STRENGTH: 500 MG 2-0-2) | Y | U | 21035 | 1000 | MG | FILM-COATED TABLET | BID | ||||
| 122367222 | 12236722 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 250 MG, 2X/DAY (BID) | Y | U | 21035 | 250 | MG | FILM-COATED TABLET | BID | ||||
| 122367222 | 12236722 | 3 | SS | Urbanyl | CLOBAZAM | 1 | Oral | 5 MG, ONCE DAILY (QD) | Y | 0 | 5 | MG | QD | ||||||
| 122367222 | 12236722 | 4 | SS | Urbanyl | CLOBAZAM | 1 | Oral | 5 MG, 2X/DAY (BID) | Y | 0 | 5 | MG | BID | ||||||
| 122367222 | 12236722 | 5 | SS | Topalgic | TRAMADOL | 1 | Oral | 50 MG, 2X/DAY (BID) | Y | U | 0 | 50 | MG | CAPSULE | BID | ||||
| 122367222 | 12236722 | 6 | SS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0.5 MG, 3X/DAY (TID); (AS NEEDED) | Y | U | 0 | .5 | MG | TID | |||||
| 122367222 | 12236722 | 7 | C | BISOPROLOL FUMARATE. | BISOPROLOL FUMARATE | 1 | Oral | 10 MG, ONCE DAILY (QD) | U | 0 | 10 | MG | QD | ||||||
| 122367222 | 12236722 | 8 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, ONCE DAILY (QD) | U | 0 | 20 | MG | QD | ||||||
| 122367222 | 12236722 | 9 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 30 MG, 3X/DAY (TID) | U | 0 | 30 | MG | TID | ||||||
| 122367222 | 12236722 | 10 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | Oral | 10 MG, ONCE DAILY (QD) | U | 0 | 10 | MG | FILM-COATED TABLET | QD | |||||
| 122367222 | 12236722 | 11 | C | Amlor | AMLODIPINE BESYLATE | 1 | Oral | 10 MG, ONCE DAILY (QD) | U | 0 | 10 | MG | CAPSULE | QD | |||||
| 122367222 | 12236722 | 12 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, ONCE DAILY (QD) | U | 0 | 40 | MG | QD | ||||||
| 122367222 | 12236722 | 13 | C | XARELTO | RIVAROXABAN | 1 | Oral | 20 MG, ONCE DAILY (QD) | U | 0 | 20 | MG | QD | ||||||
| 122367222 | 12236722 | 14 | C | Paracetamol | ACETAMINOPHEN | 1 | Oral | 2 DF, 4X/DAY (QID) (AS NEEDED) | U | 0 | 2 | DF | QID | ||||||
| 122367222 | 12236722 | 15 | C | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | 5/DAY | U | 0 | ||||||||||
| 122367222 | 12236722 | 16 | C | Rocephine | CEFTRIAXONE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 122367222 | 12236722 | 17 | C | Sodium phosphate dibasic w/sodium phosphate m | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 1 | Rectal | 1 DF, ONCE DAILY (QD) | Y | U | 0 | 1 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122367222 | 12236722 | 1 | Seizure |
| 122367222 | 12236722 | 3 | Seizure |
| 122367222 | 12236722 | 5 | Product used for unknown indication |
| 122367222 | 12236722 | 6 | Product used for unknown indication |
| 122367222 | 12236722 | 7 | Product used for unknown indication |
| 122367222 | 12236722 | 8 | Product used for unknown indication |
| 122367222 | 12236722 | 9 | Product used for unknown indication |
| 122367222 | 12236722 | 10 | Product used for unknown indication |
| 122367222 | 12236722 | 11 | Product used for unknown indication |
| 122367222 | 12236722 | 12 | Product used for unknown indication |
| 122367222 | 12236722 | 13 | Product used for unknown indication |
| 122367222 | 12236722 | 15 | Diarrhoea |
| 122367222 | 12236722 | 16 | Product used for unknown indication |
| 122367222 | 12236722 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122367222 | 12236722 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122367222 | 12236722 | Confusional state | |
| 122367222 | 12236722 | Hypertonia | |
| 122367222 | 12236722 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 122367222 | 12236722 | 1 | 20141128 | 201412 | 0 | |
| 122367222 | 12236722 | 2 | 201412 | 0 | ||
| 122367222 | 12236722 | 3 | 20141128 | 201412 | 0 | |
| 122367222 | 12236722 | 4 | 201412 | 201412 | 0 | |
| 122367222 | 12236722 | 5 | 201412 | 0 | ||
| 122367222 | 12236722 | 6 | 201412 | 0 | ||
| 122367222 | 12236722 | 15 | 20141208 | 0 | ||
| 122367222 | 12236722 | 17 | 20141210 | 0 |