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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125271901 | 12527190 | 1 | I | 201303 | 20160630 | 20160705 | 20160705 | EXP | NO-NOMAADVRE-RELISSO-2016-22265 | PHHY2016NO090554 | NOVARTIS | 76.23 | YR | F | Y | 0.00000 | 20160705 | OT | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125271901 | 12527190 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous drip | UNK | 2 | DF | Y | 21817 | SOLUTION FOR INJECTION | ||||||
| 125271901 | 12527190 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous drip | UNK | 2 | DF | Y | 21817 | SOLUTION FOR INJECTION | ||||||
| 125271901 | 12527190 | 3 | SS | PROLIA | DENOSUMAB | 1 | Subcutaneous | UNK | 3 | DF | Y | 0 | |||||||
| 125271901 | 12527190 | 4 | SS | PROLIA | DENOSUMAB | 1 | Subcutaneous | UNK | 3 | DF | Y | 0 | |||||||
| 125271901 | 12527190 | 5 | SS | PROLIA | DENOSUMAB | 1 | Subcutaneous | UNK | 3 | DF | Y | 0 | |||||||
| 125271901 | 12527190 | 6 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | UNK | U | 0 | |||||||||
| 125271901 | 12527190 | 7 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | U | 0 | ||||||||||
| 125271901 | 12527190 | 8 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125271901 | 12527190 | 1 | Osteoporosis |
| 125271901 | 12527190 | 3 | Osteoporosis |
| 125271901 | 12527190 | 6 | Cerebrovascular accident |
| 125271901 | 12527190 | 7 | Asthma |
| 125271901 | 12527190 | 8 | Cerebrovascular accident |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125271901 | 12527190 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125271901 | 12527190 | Osteitis | |
| 125271901 | 12527190 | Osteonecrosis of jaw |
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 |
|---|---|---|---|---|---|---|
| 125271901 | 12527190 | 1 | 201004 | 0 | ||
| 125271901 | 12527190 | 2 | 201104 | 201104 | 0 | |
| 125271901 | 12527190 | 3 | 20120504 | 0 | ||
| 125271901 | 12527190 | 4 | 20121204 | 0 | ||
| 125271901 | 12527190 | 5 | 20130710 | 20130710 | 0 | |
| 125271901 | 12527190 | 6 | 201303 | 0 | ||
| 125271901 | 12527190 | 8 | 201303 | 201306 | 0 |