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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127461291 | 12746129 | 1 | I | 20160802 | 20160810 | 20160915 | 20160915 | EXP | PHHY2016LV110024 | NOVARTIS | 63.00 | YR | F | Y | 53.00000 | KG | 20160915 | MD | LV | LV |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127461291 | 12746129 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, ONCE/SINGLE | 21817 | 5 | MG | SOLUTION FOR INJECTION | 1X | ||||||
| 127461291 | 12746129 | 2 | C | VIGANTOL ^MERCK^ | 2 | Oral | 5 DRP, UNK | 0 | 5 | GTT | |||||||||
| 127461291 | 12746129 | 3 | C | CALCIGRAN FORTE | 2 | Oral | 1500 MG, UNK | U | 0 | 1500 | MG | ||||||||
| 127461291 | 12746129 | 4 | C | CALCIGRAN FORTE | 2 | Oral | 1 DF, BID (500 MG CALCIUM, 200 SV (5 MKG) D3 VITAMIN (CHOLECALCIFEROLUM)) | U | 0 | 1 | DF | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127461291 | 12746129 | 1 | Osteoporotic fracture |
| 127461291 | 12746129 | 2 | Osteoporosis |
| 127461291 | 12746129 | 3 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127461291 | 12746129 | OT |
| 127461291 | 12746129 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127461291 | 12746129 | C-reactive protein increased | |
| 127461291 | 12746129 | Diplopia | |
| 127461291 | 12746129 | Eye irritation | |
| 127461291 | 12746129 | Eye pain | |
| 127461291 | 12746129 | Eye pruritus | |
| 127461291 | 12746129 | Foreign body sensation in eyes | |
| 127461291 | 12746129 | Lacrimation increased | |
| 127461291 | 12746129 | Ocular hyperaemia | |
| 127461291 | 12746129 | Photophobia | |
| 127461291 | 12746129 | Photopsia | |
| 127461291 | 12746129 | Pyrexia | |
| 127461291 | 12746129 | Red blood cell sedimentation rate increased | |
| 127461291 | 12746129 | Uveitis | |
| 127461291 | 12746129 | Visual field defect |
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 |
|---|---|---|---|---|---|---|
| 127461291 | 12746129 | 1 | 20160801 | 0 | ||
| 127461291 | 12746129 | 2 | 20130910 | 20160802 | 0 | |
| 127461291 | 12746129 | 3 | 20100910 | 20160802 | 0 |