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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125425061 | 12542506 | 1 | I | 20160624 | 20160709 | 20160709 | EXP | GB-CIPLA LTD.-2016GB08998 | CIPLA | CRABB SJ, BRADBURY J, NOLAN L, SELMAN D, MUTHURAMALINGAM SR, CAVE J, ET AL. A PHASE I CLINICAL TRIAL OF IRINOTECAN AND CARBOPLATIN IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER. CHEMOTHERAPY. 2012;58:257 TO 263 | 0.00 | Y | 0.00000 | 20160709 | OT | GB | GB |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125425061 | 12542506 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 70 MG/M2, ON DAY 1 AND 8 | 0 | 70 | MG/M**2 | INFUSION | |||||||
125425061 | 12542506 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC OF 5 ON DAY 1 | 0 | ||||||||||
125425061 | 12542506 | 3 | SS | Vincristine | VINCRISTINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
125425061 | 12542506 | 4 | SS | Doxorubicin | DOXORUBICIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
125425061 | 12542506 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
125425061 | 12542506 | 6 | C | ATROPINE. | ATROPINE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125425061 | 12542506 | 1 | Small cell lung cancer extensive stage |
125425061 | 12542506 | 2 | Small cell lung cancer extensive stage |
125425061 | 12542506 | 3 | Small cell lung cancer extensive stage |
125425061 | 12542506 | 4 | Small cell lung cancer extensive stage |
125425061 | 12542506 | 5 | Small cell lung cancer extensive stage |
125425061 | 12542506 | 6 | Prophylaxis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125425061 | 12542506 | DE |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125425061 | 12542506 | Disease progression |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |