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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127752171 | 12775217 | 1 | I | 20160901 | 0 | 20160922 | 20160922 | DIR | US-FDA-351289 | FDA-CTU | 42.00 | YR | F | N | 90.00000 | KG | 20160922 | N | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127752171 | 12775217 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 90 TAB DAILY ORAL | Y | D | 20170829 | 0 | 90 | DF | COATED TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127752171 | 12775217 | 1 | Premenstrual dysphoric disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127752171 | 12775217 | Anger | |
| 127752171 | 12775217 | Anxiety | |
| 127752171 | 12775217 | Crying | |
| 127752171 | 12775217 | Depression | |
| 127752171 | 12775217 | Feeling of despair | |
| 127752171 | 12775217 | Headache |
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 |
|---|---|---|---|---|---|---|
| 127752171 | 12775217 | 1 | 20160901 | 20160921 | 0 |