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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126540034 | 12654003 | 4 | F | 2016 | 20160912 | 20160816 | 20160921 | EXP | GB-MHRA-ADR 23580420 | GB-ACCORD-043089 | ACCORD | 47.00 | YR | F | Y | 58.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126540034 | 12654003 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | Y | 202825 | 100 | MG | ||||||||
| 126540034 | 12654003 | 2 | I | CETIRIZINE/CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | Y | CB13L51 | 0 | 10 | MG | |||||||
| 126540034 | 12654003 | 3 | I | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | PREVIOUSLY RECEIVED 100 MG ON 01-JUN-2016 | Y | 2758097 | 202825 | 150 | MG | ||||||
| 126540034 | 12654003 | 4 | C | LORATADINE. | LORATADINE | 1 | 0 | ||||||||||||
| 126540034 | 12654003 | 5 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126540034 | 12654003 | 1 | Depression |
| 126540034 | 12654003 | 2 | Multiple allergies |
| 126540034 | 12654003 | 3 | Depression |
| 126540034 | 12654003 | 4 | Product used for unknown indication |
| 126540034 | 12654003 | 5 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126540034 | 12654003 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126540034 | 12654003 | Abdominal discomfort | |
| 126540034 | 12654003 | Blood pressure systolic increased | |
| 126540034 | 12654003 | Depression | |
| 126540034 | 12654003 | Drug ineffective | |
| 126540034 | 12654003 | Drug interaction | |
| 126540034 | 12654003 | 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 |
|---|---|---|---|---|---|---|
| 126540034 | 12654003 | 1 | 2016 | 0 | ||
| 126540034 | 12654003 | 2 | 20160713 | 20160722 | 0 | |
| 126540034 | 12654003 | 3 | 2016 | 2016 | 0 |