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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126096451 | 12609645 | 1 | I | 20160625 | 20160720 | 20160801 | 20160801 | EXP | GB-MHRA-ADR 23565013 | GB-ACCORD-042708 | ACCORD | 34.00 | YR | M | Y | 78.92000 | KG | 20160801 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126096451 | 12609645 | 1 | PS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | STARTED WITH DOSE OF 25 MG FROM 29-FEB-2016 AND THEN INCREASED TO 50 MG | Y | 202446 | 50 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126096451 | 12609645 | 1 | Migraine |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126096451 | 12609645 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126096451 | 12609645 | Decreased appetite | |
| 126096451 | 12609645 | Dizziness | |
| 126096451 | 12609645 | Headache | |
| 126096451 | 12609645 | Off label use | |
| 126096451 | 12609645 | Pollakiuria | |
| 126096451 | 12609645 | Syncope | |
| 126096451 | 12609645 | Thirst |
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 |
|---|---|---|---|---|---|---|
| 126096451 | 12609645 | 1 | 20160711 | 0 |