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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127837511 | 12783751 | 1 | I | 20141026 | 20150608 | 20160927 | 20160927 | EXP | US-VALIDUS PHARMACEUTICALS LLC-US-2015VAL001416 | VALIDUS | 63.00 | YR | M | Y | 91.00000 | KG | 20160927 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127837511 | 12783751 | 1 | PS | LASIX | FUROSEMIDE | 1 | Oral | 40 MG, BID | Y | UNKNOWN | 16273 | 40 | MG | ||||||
| 127837511 | 12783751 | 2 | SS | BLINDED THERAPY | INVESTIGATIONAL PRODUCT | 1 | Oral | UNK UNK, TID | D | UNKNOWN | 0 | ||||||||
| 127837511 | 12783751 | 3 | SS | BLINDED THERAPY | INVESTIGATIONAL PRODUCT | 1 | D | 0 | |||||||||||
| 127837511 | 12783751 | 4 | SS | COCAINE | COCAINE | 1 | Unknown | UNK | U | UNKNOWN | 0 | ||||||||
| 127837511 | 12783751 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | UNK | 0 | ||||||||||
| 127837511 | 12783751 | 6 | C | OXYCODONE | OXYCODONE | 1 | Unknown | UNK | 0 | ||||||||||
| 127837511 | 12783751 | 7 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 127837511 | 12783751 | 8 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK | 0 | ||||||||||
| 127837511 | 12783751 | 9 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | UNK | 0 | ||||||||||
| 127837511 | 12783751 | 10 | C | THIAMINE. | THIAMINE | 1 | Unknown | UNK | 0 | ||||||||||
| 127837511 | 12783751 | 11 | C | SENNA | SENNA LEAFSENNOSIDESSENNOSIDES A AND B | 1 | Unknown | UNK | 0 | ||||||||||
| 127837511 | 12783751 | 12 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127837511 | 12783751 | 1 | Cardiac failure congestive |
| 127837511 | 12783751 | 2 | Osteoarthritis |
| 127837511 | 12783751 | 3 | Rheumatoid arthritis |
| 127837511 | 12783751 | 4 | Product used for unknown indication |
| 127837511 | 12783751 | 5 | Product used for unknown indication |
| 127837511 | 12783751 | 6 | Product used for unknown indication |
| 127837511 | 12783751 | 7 | Product used for unknown indication |
| 127837511 | 12783751 | 8 | Product used for unknown indication |
| 127837511 | 12783751 | 9 | Product used for unknown indication |
| 127837511 | 12783751 | 10 | Product used for unknown indication |
| 127837511 | 12783751 | 11 | Product used for unknown indication |
| 127837511 | 12783751 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127837511 | 12783751 | LT |
| 127837511 | 12783751 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127837511 | 12783751 | Abdominal pain | |
| 127837511 | 12783751 | Cardiac failure congestive | |
| 127837511 | 12783751 | Dyspnoea | |
| 127837511 | 12783751 | Hypotension |
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 |
|---|---|---|---|---|---|---|
| 127837511 | 12783751 | 1 | 20141026 | 20141027 | 0 | |
| 127837511 | 12783751 | 2 | 20130829 | 20130926 | 0 | |
| 127837511 | 12783751 | 5 | 201304 | 0 | ||
| 127837511 | 12783751 | 6 | 201305 | 0 | ||
| 127837511 | 12783751 | 7 | 201307 | 0 | ||
| 127837511 | 12783751 | 8 | 20130925 | 0 | ||
| 127837511 | 12783751 | 9 | 20130903 | 0 | ||
| 127837511 | 12783751 | 10 | 20130906 | 0 | ||
| 127837511 | 12783751 | 11 | 20130906 | 0 | ||
| 127837511 | 12783751 | 12 | 20130906 | 0 |