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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125499243 | 12549924 | 3 | F | 20160627 | 20160727 | 20160712 | 20160803 | EXP | JP-AMGEN-JPNCT2016089520 | AMGEN | 68.00 | YR | E | M | Y | 58.00000 | KG | 20160803 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125499243 | 12549924 | 1 | PS | denosumab | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q3MO | 300 | MG | 125320 | 60 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 125499243 | 12549924 | 2 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q3MO | 300 | MG | 125320 | 60 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 125499243 | 12549924 | 3 | SS | RHEUMATREX | METHOTREXATE SODIUM | 1 | Oral | 10 MG, QWK | 0 | 10 | MG | /wk | |||||||
| 125499243 | 12549924 | 4 | C | FOLIAMIN | FOLIC ACID | 1 | Oral | 6 MG, QD | 4962 | MG | 0 | 6 | MG | QD | |||||
| 125499243 | 12549924 | 5 | C | FOLIAMIN | FOLIC ACID | 1 | 4962 | MG | 0 | ||||||||||
| 125499243 | 12549924 | 6 | C | TSURUMERIN | 2 | Oral | 10 MG, QD | 0 | 10 | MG | QD | ||||||||
| 125499243 | 12549924 | 7 | C | REBAMIPIDE | REBAMIPIDE | 1 | Oral | 300 MG, QD | 0 | 300 | MG | QD | |||||||
| 125499243 | 12549924 | 8 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | 2 DF, QD | 0 | 2 | DF | QD | |||||||
| 125499243 | 12549924 | 9 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | 0 | ||||||||||||
| 125499243 | 12549924 | 10 | C | LACTEC | CALCIUM CHLORIDE ANHYDROUSPOTASSIUM CHLORIDESODIUM CHLORIDESODIUM LACTATE | 1 | Intravenous drip | 500 ML, Q3H | 0 | 500 | ML | ||||||||
| 125499243 | 12549924 | 11 | C | VITAMEDIN | CYANOCOBALAMINPYRIDOXINE HYDROCHLORIDETHIAMINE | 1 | Intravenous drip | 1 DF, BID | 0 | 1 | DF | BID | |||||||
| 125499243 | 12549924 | 12 | C | TAKEPRON | LANSOPRAZOLE | 1 | Intravenous (not otherwise specified) | 30 MG, BID | 0 | 30 | MG | BID | |||||||
| 125499243 | 12549924 | 13 | C | ISOTONIC SODIUM CHLORIDE SOLUTION | SODIUM CHLORIDE | 1 | 100 ML, UNK | 0 | 20 | ML | BID | ||||||||
| 125499243 | 12549924 | 14 | C | BFLUID | AMINO ACIDSDEXTROSEELECTROLYTES NOSVITAMINS | 1 | Intravenous drip | 500 ML, QD | 0 | 500 | ML | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125499243 | 12549924 | 1 | Rheumatoid arthritis |
| 125499243 | 12549924 | 3 | Rheumatoid arthritis |
| 125499243 | 12549924 | 4 | Prophylaxis |
| 125499243 | 12549924 | 5 | Adverse reaction |
| 125499243 | 12549924 | 6 | Myositis |
| 125499243 | 12549924 | 7 | Gastritis prophylaxis |
| 125499243 | 12549924 | 8 | Vitamin supplementation |
| 125499243 | 12549924 | 9 | Mineral supplementation |
| 125499243 | 12549924 | 10 | Fluid replacement |
| 125499243 | 12549924 | 11 | Fluid replacement |
| 125499243 | 12549924 | 12 | Abdominal discomfort |
| 125499243 | 12549924 | 13 | Gastrointestinal disorder |
| 125499243 | 12549924 | 14 | Fluid replacement |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125499243 | 12549924 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125499243 | 12549924 | Interstitial lung disease |
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 |
|---|---|---|---|---|---|---|
| 125499243 | 12549924 | 1 | 20141015 | 0 | ||
| 125499243 | 12549924 | 2 | 20151022 | 0 | ||
| 125499243 | 12549924 | 3 | 20140602 | 0 | ||
| 125499243 | 12549924 | 4 | 20140326 | 0 | ||
| 125499243 | 12549924 | 6 | 20131122 | 0 | ||
| 125499243 | 12549924 | 7 | 20131122 | 0 | ||
| 125499243 | 12549924 | 8 | 20140925 | 0 | ||
| 125499243 | 12549924 | 10 | 20160702 | 0 | ||
| 125499243 | 12549924 | 11 | 20160702 | 0 | ||
| 125499243 | 12549924 | 12 | 20160702 | 20160704 | 0 | |
| 125499243 | 12549924 | 13 | 20160702 | 0 | ||
| 125499243 | 12549924 | 14 | 20160703 | 0 |