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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127496501 | 12749650 | 1 | I | 20160701 | 20160916 | 20160916 | EXP | US-ROCHE-1831103 | ROCHE | KATZ M, QIAN S, SYED A, HERMAN J, MARSH R, COLLISSON E, SCHWARTZ L, FRANKEL W, MARTIN R, CONWAY W, TRUTY M, KINDLER H, LOWY A, BEKAII-SAAB T, PHILIP P, TALAMONTI M, CARDIN D, LOCONTE N, SHEN P, HOFFMAN J, AND VENOOK A. PREOPERATIVE MODIFIED FOLFIRINOX TREATMENT FOLLOWED BY CAPECITABINE-BASED CHEMORADIATION FOR BORDERLINE RESECTABLE PANCREATIC CANCER ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY TRIAL A021101. JAMA SURGERY 2016 AUG;151 (8):1-8. | 0.00 | Y | 0.00000 | 20160916 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127496501 | 12749650 | 1 | PS | CAPECITABINE. | CAPECITABINE | 1 | Oral | U | 20896 | 825 | MG | BID | |||||||
| 127496501 | 12749650 | 2 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 0 | 85 | MG/M**2 | |||||||||
| 127496501 | 12749650 | 3 | SS | IRINOTECAN HYDROCHLORIDE. | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 180 | MG/M**2 | |||||||||
| 127496501 | 12749650 | 4 | SS | LEUCOVORIN CALCIUM. | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | 0 | 400 | MG/M**2 | |||||||||
| 127496501 | 12749650 | 5 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 0 | 2400 | MG/M**2 | |||||||||
| 127496501 | 12749650 | 6 | C | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127496501 | 12749650 | 1 | Adenocarcinoma pancreas |
| 127496501 | 12749650 | 2 | Adenocarcinoma pancreas |
| 127496501 | 12749650 | 3 | Adenocarcinoma pancreas |
| 127496501 | 12749650 | 4 | Adenocarcinoma pancreas |
| 127496501 | 12749650 | 5 | Adenocarcinoma pancreas |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127496501 | 12749650 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127496501 | 12749650 | Acute kidney injury | |
| 127496501 | 12749650 | Alanine aminotransferase increased | |
| 127496501 | 12749650 | Anaemia | |
| 127496501 | 12749650 | Aspartate aminotransferase increased | |
| 127496501 | 12749650 | Atelectasis | |
| 127496501 | 12749650 | Decreased appetite | |
| 127496501 | 12749650 | Haemorrhage | |
| 127496501 | 12749650 | Hypoalbuminaemia | |
| 127496501 | 12749650 | Infection | |
| 127496501 | 12749650 | Lymphopenia | |
| 127496501 | 12749650 | Pleural effusion | |
| 127496501 | 12749650 | Pulmonary oedema | |
| 127496501 | 12749650 | Respiratory failure | |
| 127496501 | 12749650 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |