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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126090332 | 12609033 | 2 | F | 2012 | 20160729 | 20160731 | 20160805 | EXP | PHEH2016US018603 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160805 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126090332 | 12609033 | 1 | PS | RECLAST | ZOLEDRONIC ACID | 1 | Intravenous drip | UNK (FOUR INFUSIONS) | 21817 | ||||||||||
| 126090332 | 12609033 | 2 | SS | RECLAST | ZOLEDRONIC ACID | 1 | Unknown | UNK | 21817 | ||||||||||
| 126090332 | 12609033 | 3 | SS | RECLAST | ZOLEDRONIC ACID | 1 | Unknown | UNK | 21817 | ||||||||||
| 126090332 | 12609033 | 4 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 126090332 | 12609033 | 5 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 126090332 | 12609033 | 6 | C | CYCLOBENZAPRINE HCL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | Unknown | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 126090332 | 12609033 | 7 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 45/21, 2 PUFFS, TWICE A DAY | U | 0 | BID | ||||||||
| 126090332 | 12609033 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126090332 | 12609033 | 9 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 800 MG, QD | U | 0 | 800 | MG | QD | ||||||
| 126090332 | 12609033 | 10 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | 4000 IU, QD | U | 0 | 4000 | IU | QD | ||||||
| 126090332 | 12609033 | 11 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | 250 MG, QD | U | 0 | 250 | MG | QD | ||||||
| 126090332 | 12609033 | 12 | C | CALCIUM CITRATE | CALCIUM CITRATE | 1 | Unknown | 1000 MG, ONE PILL A WEEK | U | 0 | 1000 | MG | |||||||
| 126090332 | 12609033 | 13 | C | ADVIL | IBUPROFEN | 1 | Unknown | U | 0 | ||||||||||
| 126090332 | 12609033 | 14 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | U | 0 | ||||||||||
| 126090332 | 12609033 | 15 | C | PENICILLIN V POTASSIUM. | PENICILLIN V POTASSIUM | 1 | Unknown | U | 0 | ||||||||||
| 126090332 | 12609033 | 16 | C | LYRICA | PREGABALIN | 1 | Unknown | 50 MG, QD | U | 0 | 50 | MG | QD | ||||||
| 126090332 | 12609033 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 126090332 | 12609033 | 18 | C | FLUDROCORTISONE ACETATE. | FLUDROCORTISONE ACETATE | 1 | Unknown | U | 0 | ||||||||||
| 126090332 | 12609033 | 19 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 88 UG, QD | U | 0 | 88 | UG | QD | ||||||
| 126090332 | 12609033 | 20 | C | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | Unknown | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 126090332 | 12609033 | 21 | C | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 200 MG, BID | U | 0 | 200 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126090332 | 12609033 | 1 | Osteitis deformans |
| 126090332 | 12609033 | 4 | Product used for unknown indication |
| 126090332 | 12609033 | 6 | Product used for unknown indication |
| 126090332 | 12609033 | 7 | Product used for unknown indication |
| 126090332 | 12609033 | 8 | Product used for unknown indication |
| 126090332 | 12609033 | 9 | Product used for unknown indication |
| 126090332 | 12609033 | 10 | Product used for unknown indication |
| 126090332 | 12609033 | 11 | Product used for unknown indication |
| 126090332 | 12609033 | 12 | Product used for unknown indication |
| 126090332 | 12609033 | 13 | Product used for unknown indication |
| 126090332 | 12609033 | 14 | Product used for unknown indication |
| 126090332 | 12609033 | 15 | Product used for unknown indication |
| 126090332 | 12609033 | 16 | Product used for unknown indication |
| 126090332 | 12609033 | 17 | Product used for unknown indication |
| 126090332 | 12609033 | 18 | Product used for unknown indication |
| 126090332 | 12609033 | 19 | Product used for unknown indication |
| 126090332 | 12609033 | 20 | Product used for unknown indication |
| 126090332 | 12609033 | 21 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126090332 | 12609033 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126090332 | 12609033 | Arthralgia | |
| 126090332 | 12609033 | Bone density abnormal | |
| 126090332 | 12609033 | Inappropriate schedule of drug administration | |
| 126090332 | 12609033 | Leukaemia | |
| 126090332 | 12609033 | Nervousness |
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 |
|---|---|---|---|---|---|---|
| 126090332 | 12609033 | 1 | 201503 | 0 | ||
| 126090332 | 12609033 | 2 | 201601 | 0 | ||
| 126090332 | 12609033 | 3 | 201602 | 0 | ||
| 126090332 | 12609033 | 5 | 2010 | 0 |