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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125295351 | 12529535 | 1 | I | 20160621 | 20160706 | 20160706 | EXP | JP-CIPLA LTD.-2016JP07765 | CIPLA | 0.00 | Y | 0.00000 | 20160706 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125295351 | 12529535 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125295351 | 12529535 | 2 | SS | Irinotecan | IRINOTECAN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125295351 | 12529535 | 3 | SS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 50 MG/M2, DILUTED IN 500 ML OF NORMAL SALINE ON DAYS 1 AND 8 | U | U | 0 | 50 | MG/M**2 | ||||||
| 125295351 | 12529535 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125295351 | 12529535 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 125295351 | 12529535 | 6 | SS | Amrubicin | AMRUBICIN | 1 | Intravenous (not otherwise specified) | 100 MG/M2, 5-MINUTE INFUSION ON DAY 1 ALONE, EVERY 21 DAYS | U | U | 0 | 100 | MG/M**2 | INFUSION | |||||
| 125295351 | 12529535 | 7 | C | Granulocyte colony stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125295351 | 12529535 | 1 | Small cell lung cancer |
| 125295351 | 12529535 | 2 | Small cell lung cancer |
| 125295351 | 12529535 | 3 | Small cell lung cancer recurrent |
| 125295351 | 12529535 | 4 | Small cell lung cancer |
| 125295351 | 12529535 | 5 | Small cell lung cancer |
| 125295351 | 12529535 | 6 | Small cell lung cancer recurrent |
| 125295351 | 12529535 | 7 | Supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125295351 | 12529535 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125295351 | 12529535 | Disease recurrence | |
| 125295351 | 12529535 | Neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |