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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127364331 | 12736433 | 1 | I | 20160726 | 20160823 | 20160913 | 20160913 | EXP | BE-APOTEX-2016AP011436 | APOTEX | 36.00 | YR | M | Y | 0.00000 | 20160913 | CN | GB | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127364331 | 12736433 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | 20031 | 20 | MG | TABLET | QD | ||||||
| 127364331 | 12736433 | 2 | SS | SIMVASTATINE APOTEX, FILMOMHULDE TABLETTEN | SIMVASTATIN | 1 | Oral | 0 | TABLET | ||||||||||
| 127364331 | 12736433 | 3 | SS | ENGERIX-B | HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | 1 | Subcutaneous | 20 MCG | AHBVC490AC | 0 | 20 | UG | SOLUTION FOR INJECTION | ||||||
| 127364331 | 12736433 | 4 | SS | PANTOMED /01263204/ | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 127364331 | 12736433 | 5 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127364331 | 12736433 | 1 | Depression |
| 127364331 | 12736433 | 2 | Dyslipidaemia |
| 127364331 | 12736433 | 3 | Prophylaxis |
| 127364331 | 12736433 | 4 | Oesophagitis |
| 127364331 | 12736433 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127364331 | 12736433 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127364331 | 12736433 | Blood pressure decreased | |
| 127364331 | 12736433 | Dizziness | |
| 127364331 | 12736433 | Fatigue | |
| 127364331 | 12736433 | Hyperhidrosis | |
| 127364331 | 12736433 | Incorrect route of drug administration | |
| 127364331 | 12736433 | Loss of consciousness | |
| 127364331 | 12736433 | Malaise | |
| 127364331 | 12736433 | Migraine | |
| 127364331 | 12736433 | Pallor | |
| 127364331 | 12736433 | Tonic clonic movements |
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 |
|---|---|---|---|---|---|---|
| 127364331 | 12736433 | 3 | 20160726 | 20160726 | 0 |