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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110957495 | 11095749 | 5 | F | 20150416 | 20160714 | 20150507 | 20160725 | EXP | JP-AMGEN-JPNSP2015043608 | AMGEN | TAKATSUKA H. 10 A CASE REPORT WHICH REQUIRED HOSPITALIZATION DUE TO ADVERSE EVENT OF SUSTAINED G-CSF (G-LASTA). THE 234TH MEETING OF JAPAN SURGICAL ASSOCIATION SHIZUOKA PREFECTURE BRANCH | 41.00 | YR | A | F | Y | 54.00000 | KG | 20160724 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110957495 | 11095749 | 1 | PS | G-LASTA | PEGFILGRASTIM | 1 | Subcutaneous | 3.6 MG, 1X/3WEEKS | 14 | MG | Y | 125031 | 3.6 | MG | SOLUTION FOR INJECTION | Q3W | |||
| 110957495 | 11095749 | 2 | SS | DOCETAXEL. | DOCETAXEL | 1 | Intra-arterial | 115 MG, SINGLE | 115 | MG | 0 | 115 | MG | ||||||
| 110957495 | 11095749 | 3 | C | EPIRUBICIN HYDROCHLORIDE. | EPIRUBICIN HYDROCHLORIDE | 1 | Intravenous drip | 135 MG, 1X/3WEEKS | 540 | MG | 0 | 135 | MG | INJECTION | Q3W | ||||
| 110957495 | 11095749 | 4 | C | ENDOXAN /00021101/ | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 900 MG, 1X/3WEEKS | 3600 | MG | 0 | 900 | MG | INJECTION | Q3W | ||||
| 110957495 | 11095749 | 5 | C | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | 900 MG, 1X/3WEEKS | 3600 | MG | 0 | 900 | MG | INJECTION | Q3W |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110957495 | 11095749 | 1 | Colony stimulating factor prophylaxis |
| 110957495 | 11095749 | 2 | Breast cancer |
| 110957495 | 11095749 | 3 | Breast cancer |
| 110957495 | 11095749 | 4 | Breast cancer |
| 110957495 | 11095749 | 5 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110957495 | 11095749 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110957495 | 11095749 | Arthralgia | |
| 110957495 | 11095749 | Cough | |
| 110957495 | 11095749 | Dyspnoea | |
| 110957495 | 11095749 | Malaise | |
| 110957495 | 11095749 | Myalgia | |
| 110957495 | 11095749 | Nausea | |
| 110957495 | 11095749 | Oropharyngeal pain | |
| 110957495 | 11095749 | Pyrexia | |
| 110957495 | 11095749 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 110957495 | 11095749 | 1 | 20150122 | 20150416 | 0 | |
| 110957495 | 11095749 | 2 | 20150413 | 20150413 | 0 | |
| 110957495 | 11095749 | 3 | 20150119 | 20150323 | 0 | |
| 110957495 | 11095749 | 4 | 20150119 | 20150323 | 0 | |
| 110957495 | 11095749 | 5 | 20150119 | 20150323 | 0 |