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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111828377 | 11182837 | 7 | F | 201512 | 20160817 | 20150611 | 20160823 | EXP | PHHY2015BR066762 | NOVARTIS | 63.50 | YR | M | Y | 80.00000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111828377 | 11182837 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 1 DF (5MG/100 ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 111828377 | 11182837 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 1 DF (5MG/100ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111828377 | 11182837 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111828377 | 11182837 | OT |
| 111828377 | 11182837 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111828377 | 11182837 | Abasia | |
| 111828377 | 11182837 | Arthralgia | |
| 111828377 | 11182837 | Back pain | |
| 111828377 | 11182837 | Bone pain | |
| 111828377 | 11182837 | Concomitant disease aggravated | |
| 111828377 | 11182837 | Crepitations | |
| 111828377 | 11182837 | Dizziness | |
| 111828377 | 11182837 | Feeling abnormal | |
| 111828377 | 11182837 | Fracture | |
| 111828377 | 11182837 | Gait disturbance | |
| 111828377 | 11182837 | Lung infection | |
| 111828377 | 11182837 | Muscular weakness | |
| 111828377 | 11182837 | Myalgia | |
| 111828377 | 11182837 | Osteonecrosis | |
| 111828377 | 11182837 | Pain | |
| 111828377 | 11182837 | Pain in extremity | |
| 111828377 | 11182837 | Rib fracture | |
| 111828377 | 11182837 | Scapula fracture | |
| 111828377 | 11182837 | Spinal fracture |
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 |
|---|---|---|---|---|---|---|
| 111828377 | 11182837 | 1 | 201504 | 0 | ||
| 111828377 | 11182837 | 2 | 20150528 | 20150528 | 0 |