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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125308302 | 12530830 | 2 | F | 20140611 | 20160707 | 20160706 | 20160711 | EXP | NO-NOMAADVRE-RELISSO-2016-22264 | NO-009507513-1607NOR000068 | MERCK | 62.08 | YR | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125308302 | 12530830 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | UNK | Y | 20560 | TABLET | ||||||||
| 125308302 | 12530830 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous drip | 4 INFUSIONS OF ACLASTA IN TOTAL UNTIL 201409, LAST INFUSION BEFORE ADRS IN JULY/AUG OF 2013, | 4 | DF | U | 0 | |||||||
| 125308302 | 12530830 | 3 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4 MICROGRAMS, UNK | U | 0 | 1 | DF | |||||||
| 125308302 | 12530830 | 4 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | 40 MICROGRAM, UNK | U | 0 | 40 | UG | |||||||
| 125308302 | 12530830 | 5 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG | TABLET | ||||||
| 125308302 | 12530830 | 6 | C | CALCIGRAN FORTE | 2 | Oral | 500 MG/400 MICROGRAMS, UNK | U | 0 | ||||||||||
| 125308302 | 12530830 | 7 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 200MG, UNK | U | 0 | 200 | MG | ||||||||
| 125308302 | 12530830 | 8 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MICROGRAM, UNK | U | 0 | 18 | UG | |||||||
| 125308302 | 12530830 | 9 | C | BRONKYL | 2 | Oral | 200MG, UNK | U | 0 | 200 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125308302 | 12530830 | 1 | Osteoporosis |
| 125308302 | 12530830 | 2 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125308302 | 12530830 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125308302 | 12530830 | Osteitis | |
| 125308302 | 12530830 | 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 |
|---|---|---|---|---|---|---|
| 125308302 | 12530830 | 1 | 2005 | 2011 | 0 | |
| 125308302 | 12530830 | 2 | 2011 | 0 |