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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118792962 | 11879296 | 2 | F | 20140909 | 20160809 | 20151230 | 20160817 | EXP | PHHY2015PK169010 | NOVARTIS | 0.00 | E | F | Y | 0.00000 | 20160817 | CN | COUNTRY NOT SPECIFIED | PK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118792962 | 11879296 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118792962 | 11879296 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118792962 | 11879296 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118792962 | 11879296 | Aphasia | |
| 118792962 | 11879296 | Coordination abnormal | |
| 118792962 | 11879296 | Fall | |
| 118792962 | 11879296 | Gait disturbance | |
| 118792962 | 11879296 | Hypertension | |
| 118792962 | 11879296 | Ischaemic stroke | |
| 118792962 | 11879296 | Loss of consciousness | |
| 118792962 | 11879296 | Motor dysfunction | |
| 118792962 | 11879296 | Movement disorder | |
| 118792962 | 11879296 | Paralysis | |
| 118792962 | 11879296 | Paresis | |
| 118792962 | 11879296 | Sensory loss |
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 |
|---|---|---|---|---|---|---|
| 118792962 | 11879296 | 1 | 20130908 | 0 |