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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125282181 | 12528218 | 1 | I | 20160627 | 20160705 | 20160705 | EXP | JP-PFIZER INC-2016320700 | PFIZER | GOTO, K.. COMBINED CHEMOTHERAPY WITH CISPLATIN, ETOPOSIDE, AND IRINOTECAN VERSUS TOPOTECAN ALONE AS SECOND-LINE TREATMENT FOR PATIENTS WITH SENSITIVE RELAPSED SMALL-CELL LUNG CANCER (JCOG0605): A MULTICENTRE, OPEN-LABEL, RANDOMISED PHASE 3 TRIAL. THE LANCET. ONCOLOGY.. 2016 | 0.00 | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125282181 | 12528218 | 1 | PS | IRINOTECAN HCL | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 90 MG/M2 ON DAY 8, EVERY 2 WEEKS | U | 20571 | 90 | MG/M**2 | SOLUTION FOR INFUSION | ||||||
| 125282181 | 12528218 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 25 MG/M2 ON DAYS 1 AND 8, EVERY 2 WEEKS | U | 0 | 25 | MG/M**2 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125282181 | 12528218 | 3 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 60 MG/M2 ON DAYS 1-3, EVERY 2 WEEKS | U | 0 | 60 | MG/M**2 | |||||||
| 125282181 | 12528218 | 4 | C | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Subcutaneous | UNK, DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125282181 | 12528218 | 1 | Small cell lung cancer |
| 125282181 | 12528218 | 2 | Small cell lung cancer |
| 125282181 | 12528218 | 3 | Small cell lung cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125282181 | 12528218 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125282181 | 12528218 | Febrile neutropenia | |
| 125282181 | 12528218 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |