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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113226343 | 11322634 | 3 | F | 20150722 | 20160824 | 20150730 | 20160830 | EXP | IT-ROCHE-1614636 | ROCHE | 54.39 | YR | F | Y | 100.00000 | KG | 20160830 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113226343 | 11322634 | 1 | PS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 150 MG -1 VIAL FOR INTRAVENOUS USE | Y | N1031B03 | 103792 | 800 | MG | SOLUTION FOR INFUSION | /cycle | ||||
| 113226343 | 11322634 | 2 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | TABLET | ||||||||
| 113226343 | 11322634 | 3 | C | DEXAMETHASONE PHOSPHATE | DEXAMETHASONE PHOSPHATE | 1 | Unknown | 0 | 12 | MG | SOLUTION FOR INFUSION | ||||||||
| 113226343 | 11322634 | 4 | C | DEXAMETHASONE PHOSPHATE | DEXAMETHASONE PHOSPHATE | 1 | Oral | 0 | 2 | MG | QD | ||||||||
| 113226343 | 11322634 | 5 | C | DEXAMETHASONE PHOSPHATE | DEXAMETHASONE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 0 | 4 | MG | QOD | ||||||||
| 113226343 | 11322634 | 6 | C | DEXAMETHASONE PHOSPHATE | DEXAMETHASONE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 0 | 12 | MG | |||||||||
| 113226343 | 11322634 | 7 | C | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 8 | MG | SOLUTION FOR INJECTION | ||||||||
| 113226343 | 11322634 | 8 | C | DOCETAXEL. | DOCETAXEL | 1 | Intravenous drip | 10 MG/ML- 1 X 160 MG/16 ML VIAL | 0 | 109 | MG | SOLUTION FOR INFUSION | |||||||
| 113226343 | 11322634 | 9 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | 875 MG/125 MG - 12 SACHETS | 0 | 1750 | MG | ||||||||
| 113226343 | 11322634 | 10 | C | LEVOXACIN | LEVOFLOXACIN | 1 | Oral | 500 MG FILM-COATED TABLETS- 5 TABLETS | 0 | 500 | MG | FILM-COATED TABLET | |||||||
| 113226343 | 11322634 | 11 | C | CARDIOASPIRIN | ASPIRIN | 1 | Oral | 100 MG-30 TABLETS | 0 | 100 | MG | ||||||||
| 113226343 | 11322634 | 12 | C | LETROZOLE. | LETROZOLE | 1 | Oral | 0 | 2.5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113226343 | 11322634 | 1 | HER-2 positive breast cancer |
| 113226343 | 11322634 | 2 | Gastritis |
| 113226343 | 11322634 | 3 | Vomiting |
| 113226343 | 11322634 | 7 | Vomiting |
| 113226343 | 11322634 | 8 | HER-2 positive breast cancer |
| 113226343 | 11322634 | 9 | Bacterial infection |
| 113226343 | 11322634 | 10 | Bacterial infection |
| 113226343 | 11322634 | 11 | Atrial septal defect |
| 113226343 | 11322634 | 12 | HER-2 positive breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113226343 | 11322634 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113226343 | 11322634 | Chills | |
| 113226343 | 11322634 | Dyspnoea | |
| 113226343 | 11322634 | Hyperthermia | |
| 113226343 | 11322634 | Infusion related reaction |
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 |
|---|---|---|---|---|---|---|
| 113226343 | 11322634 | 1 | 20150722 | 20150722 | 0 | |
| 113226343 | 11322634 | 2 | 20150702 | 20150722 | 0 | |
| 113226343 | 11322634 | 3 | 20150626 | 20150722 | 0 | |
| 113226343 | 11322634 | 4 | 20150716 | 0 | ||
| 113226343 | 11322634 | 5 | 20150720 | 0 | ||
| 113226343 | 11322634 | 6 | 20150722 | 0 | ||
| 113226343 | 11322634 | 7 | 20150722 | 20150722 | 0 | |
| 113226343 | 11322634 | 8 | 20150722 | 20150722 | 0 | |
| 113226343 | 11322634 | 9 | 20150720 | 20150722 | 0 | |
| 113226343 | 11322634 | 10 | 20150720 | 20150722 | 0 | |
| 113226343 | 11322634 | 11 | 20090101 | 20150722 | 0 | |
| 113226343 | 11322634 | 12 | 20150714 | 20150722 | 0 |