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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127118922 | 12711892 | 2 | F | 20160912 | 20160902 | 20160915 | EXP | PHHY2015BR074090 | NOVARTIS | 0.00 | F | Y | 69.00000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127118922 | 12711892 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | UNK | SA390 | 21817 | SOLUTION FOR INJECTION | ||||||||
| 127118922 | 12711892 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | SA778 | 21817 | 5 | MG | SOLUTION FOR INJECTION | ||||||
| 127118922 | 12711892 | 3 | SS | CALCIUM D3 SANDOZ | CALCIUMCHOLECALCIFEROL | 1 | Unknown | 0 | |||||||||||
| 127118922 | 12711892 | 4 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | U | 0 | ||||||||||
| 127118922 | 12711892 | 5 | C | MELOXICAM. | MELOXICAM | 1 | Unknown | U | 0 | ||||||||||
| 127118922 | 12711892 | 6 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | U | 0 | ||||||||||
| 127118922 | 12711892 | 7 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 8 DRP, QD | U | 0 | 8 | GTT | QD | ||||||
| 127118922 | 12711892 | 8 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Oral | 5 IU, QW | U | 0 | 5 | IU | TABLET | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127118922 | 12711892 | 1 | Osteoporosis |
| 127118922 | 12711892 | 3 | Product used for unknown indication |
| 127118922 | 12711892 | 4 | Product used for unknown indication |
| 127118922 | 12711892 | 5 | Product used for unknown indication |
| 127118922 | 12711892 | 6 | Product used for unknown indication |
| 127118922 | 12711892 | 7 | Product used for unknown indication |
| 127118922 | 12711892 | 8 | Mineral supplementation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127118922 | 12711892 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127118922 | 12711892 | Arthralgia | |
| 127118922 | 12711892 | Back pain | |
| 127118922 | 12711892 | Body height decreased | |
| 127118922 | 12711892 | Diarrhoea | |
| 127118922 | 12711892 | Eating disorder | |
| 127118922 | 12711892 | Haemangioma | |
| 127118922 | 12711892 | Haemorrhage | |
| 127118922 | 12711892 | Headache | |
| 127118922 | 12711892 | Hernia pain | |
| 127118922 | 12711892 | Hiatus hernia | |
| 127118922 | 12711892 | Intervertebral disc protrusion | |
| 127118922 | 12711892 | Malaise | |
| 127118922 | 12711892 | Musculoskeletal pain | |
| 127118922 | 12711892 | Pain in extremity | |
| 127118922 | 12711892 | Pruritus | |
| 127118922 | 12711892 | Rash | |
| 127118922 | 12711892 | Spinal pain | |
| 127118922 | 12711892 | Vomiting | |
| 127118922 | 12711892 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127118922 | 12711892 | 1 | 20150415 | 0 | ||
| 127118922 | 12711892 | 2 | 20160415 | 0 |