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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125299991 | 12529999 | 1 | I | 20111122 | 20160706 | 20160706 | EXP | DE-CIPLA LTD.-2011DE00221 | CIPLA | SEHOULI J, ALVAREZ AM, MANOUCHEHRPOUR S, GHATAGE P, SZCZYLIK C, ZIMMERMANN A ET AL.,. A PHASE II TRIAL OF PEMETREXED IN COMBINATION WITH CARBOPLATIN IN PATIENTS WITH RECURRENT OVARIAN OR PRIMARY PERITONEAL CANCER. GYNECOLOGIC ONCOLOGY. 2012;124:205 TO 209 | 0.00 | Y | 0.00000 | 20160706 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125299991 | 12529999 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | AUC 6, AS 30 MIN INFUSION ON DAY 1 OF A 21 DAY CYCLE | U | 0 | INFUSION | ||||||||
| 125299991 | 12529999 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | U | 0 | INFUSION | ||||||||||
| 125299991 | 12529999 | 3 | SS | Pemetrexed | PEMETREXED | 1 | Intravenous (not otherwise specified) | 500 MG/M2, OVER 10 MIN, ON DAY 1 | U | U | 0 | 500 | MG/M**2 | INFUSION | |||||
| 125299991 | 12529999 | 4 | SS | Pemetrexed | PEMETREXED | 1 | U | U | 0 | INFUSION | |||||||||
| 125299991 | 12529999 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | UNK (350-1000 MICRO GRAMS) | U | U | 0 | ||||||||
| 125299991 | 12529999 | 6 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Intramuscular | 1000 MICROGRAMS, EVERY 9 WEEKS | U | U | 0 | 1000 | UG | ||||||
| 125299991 | 12529999 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 4 MG, BID, FOR THREE 3 DAYS STARTING 1 DAY BEFORE PEMETREXED | U | U | 0 | 4 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125299991 | 12529999 | 1 | Ovarian cancer recurrent |
| 125299991 | 12529999 | 2 | Malignant peritoneal neoplasm |
| 125299991 | 12529999 | 3 | Ovarian cancer recurrent |
| 125299991 | 12529999 | 4 | Malignant peritoneal neoplasm |
| 125299991 | 12529999 | 7 | Allergy prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125299991 | 12529999 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125299991 | 12529999 | Dyspnoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |