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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125512151 | 12551215 | 1 | I | 20160628 | 20160713 | 20160713 | EXP | JP-CIPLA LTD.-2016JP08449 | CIPLA | OKUMA Y, HOSOMI Y, TAKAHASHI S, NAKAHARA Y, WATANABE K, NAGAMATA M ET AL.,. A PHASE II STUDY OF NANOPARTICLE ALBUMIN-BOUND PACLITAXEL PLUS CARBOPLATIN AS THE FIRST-LINE THERAPY IN ELDERLY PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SMALL CELL LUNG CANCER. CANCER CHEMOTHER PHARMACOL. 2016 | 0.00 | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125512151 | 12551215 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | (AUC) 6 ON DAY 1 OF EACH 21-DAY CYCLE | U | U | 0 | ||||||||
| 125512151 | 12551215 | 2 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 100 MG/M2, OVER 30 MIN ON DAYS 1, 8, AND 15 OF EACH 21-DAY CYCLE | U | U | 0 | 100 | MG/M**2 | INFUSION | |||||
| 125512151 | 12551215 | 3 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 6.6 MG, UNK | U | U | 0 | 6.6 | MG | ||||||
| 125512151 | 12551215 | 4 | C | PALONOSETRON HYDROCHLORIDE. | PALONOSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0.75 MG, UNK | U | U | 0 | .75 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125512151 | 12551215 | 1 | Non-small cell lung cancer |
| 125512151 | 12551215 | 2 | Non-small cell lung cancer |
| 125512151 | 12551215 | 3 | Antiemetic supportive care |
| 125512151 | 12551215 | 4 | Antiemetic supportive care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125512151 | 12551215 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125512151 | 12551215 | Cardiac arrest | |
| 125512151 | 12551215 | Febrile neutropenia | |
| 125512151 | 12551215 | Lung infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |