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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126772891 | 12677289 | 1 | I | 20160809 | 20160817 | 20160823 | 20160823 | EXP | PHEH2016US020922 | NOVARTIS | 52.52 | YR | Y | 52.17000 | KG | 20160823 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126772891 | 12677289 | 1 | PS | RECLAST | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | (SINGLE DOSE) | 21817 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126772891 | 12677289 | 1 | Osteopenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126772891 | 12677289 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126772891 | 12677289 | Arthralgia | |
| 126772891 | 12677289 | Bone pain | |
| 126772891 | 12677289 | Dyspnoea | |
| 126772891 | 12677289 | Inflammation | |
| 126772891 | 12677289 | Pyrexia | |
| 126772891 | 12677289 | Septic shock | |
| 126772891 | 12677289 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 126772891 | 12677289 | 1 | 20160809 | 0 |