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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125658091 | 12565809 | 1 | I | 20160706 | 20160718 | 20160718 | EXP | PHEH2016US016897 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160718 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125658091 | 12565809 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | 300 MG, BID | 21014 | 300 | MG | TABLET | BID | ||||||
| 125658091 | 12565809 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1 DF, QD (1350 MG) | 21014 | 1 | DF | TABLET | QD | ||||||
| 125658091 | 12565809 | 3 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 125658091 | 12565809 | 4 | C | TEKTURNA | ALISKIREN HEMIFUMARATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125658091 | 12565809 | 1 | Product used for unknown indication |
| 125658091 | 12565809 | 3 | Product used for unknown indication |
| 125658091 | 12565809 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125658091 | 12565809 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125658091 | 12565809 | Asthenia | |
| 125658091 | 12565809 | Drug dependence | |
| 125658091 | 12565809 | Drug effect decreased | |
| 125658091 | 12565809 | Drug hypersensitivity | |
| 125658091 | 12565809 | Drug ineffective |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |