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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117823043 | 11782304 | 3 | F | 20150709 | 20160811 | 20151127 | 20160815 | EXP | ES-AMGEN-ESPCT2015125696 | AMGEN | 64.00 | YR | A | M | Y | 63.00000 | KG | 20160815 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117823043 | 11782304 | 1 | PS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, Q3WK | 125320 | 120 | MG | SOLUTION FOR INJECTION | Q3W | ||||||
| 117823043 | 11782304 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | 500 MG, Q3WK | 0 | 500 | MG | Q3W | |||||||
| 117823043 | 11782304 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 2200 MG, 8 OF THREE WEEK CYCLE. | 0 | 2200 | MG | ||||||||
| 117823043 | 11782304 | 4 | C | CALCIUM | CALCIUM | 1 | Oral | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 117823043 | 11782304 | 5 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 117823043 | 11782304 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 4 UNK, UNK | 0 | 4 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117823043 | 11782304 | 1 | Non-small cell lung cancer stage IV |
| 117823043 | 11782304 | 2 | Non-small cell lung cancer stage IV |
| 117823043 | 11782304 | 3 | Non-small cell lung cancer stage IV |
| 117823043 | 11782304 | 4 | Metastases to bone |
| 117823043 | 11782304 | 5 | Hypocalcaemia |
| 117823043 | 11782304 | 6 | Neoplasm malignant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117823043 | 11782304 | LT |
| 117823043 | 11782304 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117823043 | 11782304 | Hypocalcaemia | |
| 117823043 | 11782304 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 117823043 | 11782304 | 1 | 20150616 | 0 | ||
| 117823043 | 11782304 | 2 | 20150616 | 0 | ||
| 117823043 | 11782304 | 3 | 20150616 | 0 | ||
| 117823043 | 11782304 | 4 | 20150616 | 201509 | 0 | |
| 117823043 | 11782304 | 6 | 20150527 | 0 |