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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125358331 | 12535833 | 1 | I | 20160206 | 20160624 | 20160707 | 20160707 | EXP | GB-MHRA-EYC 00141277 | GB-WATSON-2016-14643 | WATSON | 71.00 | YR | M | Y | 83.91000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125358331 | 12535833 | 1 | SS | Atorvastatin (Unknown) | ATORVASTATIN | 1 | Oral | 40 MG, UNKNOWN | Y | UNCONFIRMED | 0 | 40 | MG | UNK | |||||
| 125358331 | 12535833 | 2 | PS | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 10 MG, DAILY | Y | UNCONFIRMED | 76939 | 10 | MG | UNK | QD | ||||
| 125358331 | 12535833 | 3 | SS | Simvastatin (Unknown) | SIMVASTATIN | 1 | Oral | 10 MG, UNKNOWN | Y | UNCONFIRMED | 0 | 10 | MG | UNK | |||||
| 125358331 | 12535833 | 4 | C | BENDROFLUMETHIAZIDE | BENDROFLUMETHIAZIDE | 1 | Oral | 2.5 MG, DAILY | U | 0 | 2.5 | MG | QD | ||||||
| 125358331 | 12535833 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 5 MG, 1/WEEK | U | 0 | 5 | MG | /wk | ||||||
| 125358331 | 12535833 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 15 MG, 1/WEEK | U | 0 | 15 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125358331 | 12535833 | 1 | Blood cholesterol increased |
| 125358331 | 12535833 | 2 | Blood cholesterol increased |
| 125358331 | 12535833 | 3 | Blood cholesterol increased |
| 125358331 | 12535833 | 4 | Product used for unknown indication |
| 125358331 | 12535833 | 5 | Product used for unknown indication |
| 125358331 | 12535833 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125358331 | 12535833 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125358331 | 12535833 | Abdominal pain | |
| 125358331 | 12535833 | Epistaxis | |
| 125358331 | 12535833 | Flatulence | |
| 125358331 | 12535833 | Gastrointestinal disorder | |
| 125358331 | 12535833 | Muscle spasms |
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 |
|---|---|---|---|---|---|---|
| 125358331 | 12535833 | 1 | 20160128 | 20160214 | 0 | |
| 125358331 | 12535833 | 2 | 20160510 | 20160528 | 0 | |
| 125358331 | 12535833 | 3 | 20160322 | 20160324 | 0 |