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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103327224 | 10332722 | 4 | F | 2013 | 20160914 | 20140722 | 20160919 | EXP | PHHY2014BR089159 | NOVARTIS | 0.00 | F | Y | 63.00000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103327224 | 10332722 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | D | 21817 | 5 | MG | SOLUTION FOR INJECTION | ||||||
| 103327224 | 10332722 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | UNK | D | 21817 | SOLUTION FOR INJECTION | ||||||||
| 103327224 | 10332722 | 3 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | UNK | D | 21817 | SOLUTION FOR INJECTION | ||||||||
| 103327224 | 10332722 | 4 | C | VALIUM | DIAZEPAM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 103327224 | 10332722 | 5 | C | FRONTAL | ALPRAZOLAM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 103327224 | 10332722 | 6 | C | VELIJA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 103327224 | 10332722 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 103327224 | 10332722 | 8 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103327224 | 10332722 | 1 | Osteoporosis |
| 103327224 | 10332722 | 2 | Osteopenia |
| 103327224 | 10332722 | 4 | Depression |
| 103327224 | 10332722 | 5 | Sleep disorder |
| 103327224 | 10332722 | 6 | Sleep disorder |
| 103327224 | 10332722 | 7 | Sedative therapy |
| 103327224 | 10332722 | 8 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103327224 | 10332722 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103327224 | 10332722 | Adrenal cyst | |
| 103327224 | 10332722 | Adverse reaction | |
| 103327224 | 10332722 | Concomitant disease aggravated | |
| 103327224 | 10332722 | Fear | |
| 103327224 | 10332722 | Gingival swelling | |
| 103327224 | 10332722 | Headache | |
| 103327224 | 10332722 | Hypoaesthesia oral | |
| 103327224 | 10332722 | Localised infection | |
| 103327224 | 10332722 | Oral pain | |
| 103327224 | 10332722 | Pain | |
| 103327224 | 10332722 | Pain in jaw | |
| 103327224 | 10332722 | Pancreatic cyst | |
| 103327224 | 10332722 | Paraesthesia | |
| 103327224 | 10332722 | Pneumonia | |
| 103327224 | 10332722 | Pruritus | |
| 103327224 | 10332722 | Pyrexia | |
| 103327224 | 10332722 | Renal cyst | |
| 103327224 | 10332722 | Spinal pain | |
| 103327224 | 10332722 | Swelling face | |
| 103327224 | 10332722 | Tooth disorder | |
| 103327224 | 10332722 | Tooth loss | |
| 103327224 | 10332722 | Toothache |
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 |
|---|---|---|---|---|---|---|
| 103327224 | 10332722 | 1 | 20130822 | 0 | ||
| 103327224 | 10332722 | 2 | 201501 | 0 | ||
| 103327224 | 10332722 | 3 | 20160120 | 0 |