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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120934583 | 12093458 | 3 | F | 20151209 | 20160712 | 20160219 | 20160719 | EXP | FR-AMGEN-FRASP2016017663 | AMGEN | 39.00 | YR | A | F | Y | 0.00000 | 20160719 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120934583 | 12093458 | 1 | PS | XGEVA | DENOSUMAB | 1 | Unknown | 120 MG, QMO | 125320 | 120 | MG | SOLUTION FOR INJECTION | /month | ||||||
| 120934583 | 12093458 | 2 | SS | TRASTUZUMAB EMTANSINE | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | 288 MG, Q3WK | 1147415 | 0 | 288 | MG | Q3W | ||||||
| 120934583 | 12093458 | 3 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | 1300 MG, BID | 0 | 1300 | MG | BID | |||||||
| 120934583 | 12093458 | 4 | SS | CAPECITABINE. | CAPECITABINE | 1 | Oral | 1300 MG, BID | 0 | 1300 | MG | BID | |||||||
| 120934583 | 12093458 | 5 | SS | CACIT D3 | CALCIUMCHOLECALCIFEROL | 1 | Unknown | 2 DF, BID | 0 | 2 | DF | BID | |||||||
| 120934583 | 12093458 | 6 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 8 DF TABLETS, UNK | 0 | 8 | DF | ||||||||
| 120934583 | 12093458 | 7 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 3 DF TABLETS, UNK | 0 | 3 | DF | ||||||||
| 120934583 | 12093458 | 8 | C | SPASFON | PHLOROGLUCINOL | 1 | Oral | 6 TABLETS, UNK | 0 | 6 | DF | ||||||||
| 120934583 | 12093458 | 9 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | 40 MG, UNK | 0 | 40 | MG | |||||||||
| 120934583 | 12093458 | 10 | C | OROCAL D3 | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | 2 DF, TABLETS UNK | 0 | 2 | DF | ||||||||
| 120934583 | 12093458 | 11 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | 4000 IU, QD | 0 | 4000 | IU | QD | ||||||||
| 120934583 | 12093458 | 12 | C | ACUPAN | NEFOPAM HYDROCHLORIDE | 1 | 20 MG, UNK | 0 | 20 | MG | |||||||||
| 120934583 | 12093458 | 13 | C | FORLAX | POLYETHYLENE GLYCOL 4000 | 1 | 2 SACHET, QD | 0 | QD | ||||||||||
| 120934583 | 12093458 | 14 | C | LYRICA | PREGABALIN | 1 | 150 MG, UNK | 0 | 150 | MG | QD | ||||||||
| 120934583 | 12093458 | 15 | C | ROCEPHINE | CEFTRIAXONE SODIUM | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 120934583 | 12093458 | 16 | C | ZOPHREN | ONDANSETRON | 1 | 8 MG, UNK | 0 | 8 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120934583 | 12093458 | 1 | Product used for unknown indication |
| 120934583 | 12093458 | 2 | HER-2 positive breast cancer |
| 120934583 | 12093458 | 3 | HER-2 positive breast cancer |
| 120934583 | 12093458 | 5 | Bone cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120934583 | 12093458 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120934583 | 12093458 | Abdominal pain | |
| 120934583 | 12093458 | Abdominal pain upper | |
| 120934583 | 12093458 | Headache | |
| 120934583 | 12093458 | Intestinal obstruction | |
| 120934583 | 12093458 | Nausea | |
| 120934583 | 12093458 | Pyrexia | |
| 120934583 | 12093458 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 120934583 | 12093458 | 1 | 20150923 | 0 | ||
| 120934583 | 12093458 | 2 | 20151028 | 0 | ||
| 120934583 | 12093458 | 3 | 20151028 | 0 | ||
| 120934583 | 12093458 | 4 | 20151028 | 0 | ||
| 120934583 | 12093458 | 5 | 20151028 | 0 | ||
| 120934583 | 12093458 | 6 | 20160121 | 0 | ||
| 120934583 | 12093458 | 7 | 20160121 | 0 | ||
| 120934583 | 12093458 | 8 | 20160121 | 0 | ||
| 120934583 | 12093458 | 9 | 20160121 | 0 | ||
| 120934583 | 12093458 | 10 | 20160121 | 0 | ||
| 120934583 | 12093458 | 11 | 20160121 | 20160125 | 0 | |
| 120934583 | 12093458 | 12 | 20160121 | 20160125 | 0 | |
| 120934583 | 12093458 | 13 | 20160121 | 0 | ||
| 120934583 | 12093458 | 14 | 20160121 | 0 | ||
| 120934583 | 12093458 | 15 | 20160110 | 0 | ||
| 120934583 | 12093458 | 16 | 20151028 | 20151230 | 0 |