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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127153961 | 12715396 | 1 | I | 20160830 | 20160906 | 20160906 | EXP | GB-MHRA-MIDB-AE2EB8D3-0491-4AB4-B503-ADC3A2F2E497 | GB-UCBSA-2016033690 | UCB | 14.00 | YR | F | Y | 0.00000 | 20160906 | PH | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127153961 | 12715396 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 10 ML, 3X/DAY (TID) | 21505 | 10 | ML | ORAL SOLUTION | TID | ||||||
| 127153961 | 12715396 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 5 ML, ONCE DAILY (QD) | 0 | 5 | ML | QD | |||||||
| 127153961 | 12715396 | 3 | SS | PHENYTOIN. | PHENYTOIN | 1 | Oral | 5.5 ML, 2X/DAY (BID) | 0 | 5.5 | ML | BID | |||||||
| 127153961 | 12715396 | 4 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Oral | 12.5 ML, 3X/DAY (TID) | U | 0 | 12.5 | ML | TID | ||||||
| 127153961 | 12715396 | 5 | C | Clobazam | CLOBAZAM | 1 | Oral | 5 ML, 2X/DAY (BID) | U | 0 | 5 | ML | BID | ||||||
| 127153961 | 12715396 | 6 | C | COLISTIMETHATE | COLISTIMETHATE SODIUM | 1 | 1 DF, 2X/DAY (BID) | U | 0 | 1 | DF | BID | |||||||
| 127153961 | 12715396 | 7 | C | Dornase alfa | DORNASE ALFA | 1 | 1 DF, 2X/DAY (BID) | U | 0 | 1 | DF | BID | |||||||
| 127153961 | 12715396 | 8 | C | LACOSAMIDE. | LACOSAMIDE | 1 | Oral | 20 ML, 2X/DAY (BID) | U | 0 | 20 | ML | BID | ||||||
| 127153961 | 12715396 | 9 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 10 ML, 3X/DAY (TID) | U | 0 | 10 | ML | TID | ||||||
| 127153961 | 12715396 | 10 | C | Melatonin | MELATONIN | 1 | Oral | 5 MG, ONCE DAILY (QD) | U | 0 | 5 | MG | QD | ||||||
| 127153961 | 12715396 | 11 | C | Paracetamol | ACETAMINOPHEN | 1 | Oral | 10 ML, 3X/DAY (TID) | U | 0 | 10 | ML | TID | ||||||
| 127153961 | 12715396 | 12 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Oral | 7.5 ML, 2X/DAY (BID) | U | 0 | 7.5 | ML | BID | ||||||
| 127153961 | 12715396 | 13 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 8 DF, ONCE DAILY (QD); STRENGTH: 5 MG | U | 0 | 8 | DF | QD | ||||||
| 127153961 | 12715396 | 14 | C | Sodium picosulfate | SODIUM PICOSULFATE | 1 | Oral | 10 ML, ONCE DAILY (QD) | U | 0 | 10 | ML | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127153961 | 12715396 | 1 | Product used for unknown indication |
| 127153961 | 12715396 | 2 | Product used for unknown indication |
| 127153961 | 12715396 | 3 | Product used for unknown indication |
| 127153961 | 12715396 | 4 | Product used for unknown indication |
| 127153961 | 12715396 | 5 | Product used for unknown indication |
| 127153961 | 12715396 | 6 | Product used for unknown indication |
| 127153961 | 12715396 | 7 | Product used for unknown indication |
| 127153961 | 12715396 | 8 | Product used for unknown indication |
| 127153961 | 12715396 | 9 | Product used for unknown indication |
| 127153961 | 12715396 | 10 | Product used for unknown indication |
| 127153961 | 12715396 | 11 | Product used for unknown indication |
| 127153961 | 12715396 | 12 | Product used for unknown indication |
| 127153961 | 12715396 | 13 | Product used for unknown indication |
| 127153961 | 12715396 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127153961 | 12715396 | OT |
| 127153961 | 12715396 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127153961 | 12715396 | Neutropenia | |
| 127153961 | 12715396 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |