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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125314022 | 12531402 | 2 | F | 20150312 | 20160706 | 20160706 | 20160712 | EXP | ES-AGEMED-310720444 | ES-UCBSA-2016024973 | UCB | 88.00 | YR | M | Y | 0.00000 | 20160712 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125314022 | 12531402 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 125 MG, 2X/DAY (BID), 1/2-0-1/2 | Y | U | 21035 | 125 | MG | BID | |||||
| 125314022 | 12531402 | 2 | SS | ARICEPT | DONEPEZIL HYDROCHLORIDE | 1 | Oral | 10 MG, ONCE DAILY (QD), 0-0-1 | Y | U | 0 | 10 | MG | QD | |||||
| 125314022 | 12531402 | 3 | SS | Furosemida | FUROSEMIDE | 1 | Oral | 20 MG, ONCE DAILY (QD), 1/2-0-0 | Y | U | 0 | 20 | MG | QD | |||||
| 125314022 | 12531402 | 4 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 1 MG, ONCE DAILY (QD), 1 CP CENA | 0 | 1 | MG | QD | |||||||
| 125314022 | 12531402 | 5 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 1 MG, ONCE DAILY (QD), 1 CP A LAS 23 HORAS | 0 | 1 | MG | QD | |||||||
| 125314022 | 12531402 | 6 | C | Mirtazapina | MIRTAZAPINE | 1 | Oral | 15 MG, ONCE DAILY (QD), 1 CP CENA | 0 | 15 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125314022 | 12531402 | 1 | Product used for unknown indication |
| 125314022 | 12531402 | 2 | Dementia |
| 125314022 | 12531402 | 3 | Hypertension |
| 125314022 | 12531402 | 4 | Agitation |
| 125314022 | 12531402 | 5 | Insomnia |
| 125314022 | 12531402 | 6 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125314022 | 12531402 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125314022 | 12531402 | Inappropriate antidiuretic hormone secretion | |
| 125314022 | 12531402 | Inappropriate schedule of drug administration | |
| 125314022 | 12531402 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125314022 | 12531402 | 1 | 20150209 | 20150312 | 0 | |
| 125314022 | 12531402 | 2 | 20150226 | 20150312 | 0 | |
| 125314022 | 12531402 | 3 | 20150222 | 20150312 | 0 | |
| 125314022 | 12531402 | 4 | 20140915 | 0 | ||
| 125314022 | 12531402 | 5 | 20141224 | 0 |