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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101925117 | 10192511 | 7 | F | 2013 | 20160720 | 20140523 | 20160727 | EXP | PHHY2014BR063046 | NOVARTIS | 40.91 | YR | F | Y | 40.00000 | KG | 20160727 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 101925117 | 10192511 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 101925117 | 10192511 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | SC287 | 21817 | 5 | MG | SOLUTION FOR INJECTION | ||||||
| 101925117 | 10192511 | 3 | C | ZELMAC | TEGASEROD | 1 | Oral | 1 DF, QD (8 YEARS AGO) | 0 | 1 | DF | TABLET | QD | ||||||
| 101925117 | 10192511 | 4 | C | NEXIUM I.V. | ESOMEPRAZOLE SODIUM | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 101925117 | 10192511 | 1 | Osteoporosis |
| 101925117 | 10192511 | 2 | Prophylaxis |
| 101925117 | 10192511 | 3 | Dyspepsia |
| 101925117 | 10192511 | 4 | Dyspepsia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 101925117 | 10192511 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 101925117 | 10192511 | Abdominal pain upper | |
| 101925117 | 10192511 | Agitation | |
| 101925117 | 10192511 | Anxiety | |
| 101925117 | 10192511 | Gastritis | |
| 101925117 | 10192511 | Infusion site extravasation | |
| 101925117 | 10192511 | Nervousness | |
| 101925117 | 10192511 | Peripheral swelling | |
| 101925117 | 10192511 | Poor venous access | |
| 101925117 | 10192511 | Quadriplegia | |
| 101925117 | 10192511 | Underdose | |
| 101925117 | 10192511 | Urinary tract disorder | |
| 101925117 | 10192511 | Urinary tract infection enterococcal |
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 |
|---|---|---|---|---|---|---|
| 101925117 | 10192511 | 1 | 2008 | 0 | ||
| 101925117 | 10192511 | 2 | 20160706 | 0 | ||
| 101925117 | 10192511 | 3 | 2009 | 0 | ||
| 101925117 | 10192511 | 4 | 2012 | 0 |