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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127437002 | 12743700 | 2 | F | 20160922 | 20160914 | 20160930 | EXP | US-TEVA-691605USA | TEVA | ANDERSON BJ, PETERSON LL. SYSTEMIC CAPILLARY LEAK SYNDROME IN A PATIENT RECEIVING ADJUVANT OXALIPLATIN FOR LOCALLY ADVANCED COLON CANCER. J-ONCOL-PHARM-PRACT 2016;22(5):725-728. | 63.00 | YR | M | Y | 0.00000 | 20160930 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127437002 | 12743700 | 1 | PS | OXALIPLATIN INJECTION 50MG/10 ML and 100MG/20ML | OXALIPLATIN | 1 | Other | 12 CYCLES | Y | 22160 | |||||||||
| 127437002 | 12743700 | 2 | SS | LITHIUM. | LITHIUM | 1 | Unknown | U | 0 | ||||||||||
| 127437002 | 12743700 | 3 | C | folinic acid | LEUCOVORIN | 1 | Unknown | RECEIVED 11 CYCLES | U | 0 | |||||||||
| 127437002 | 12743700 | 4 | C | FLUOROURACIL. | FLUOROURACIL | 1 | Other | RECEIVED 11 CYCLES | U | 0 | |||||||||
| 127437002 | 12743700 | 5 | C | ondansetron | ONDANSETRON | 1 | Unknown | U | 0 | ||||||||||
| 127437002 | 12743700 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127437002 | 12743700 | 1 | Adenocarcinoma of colon |
| 127437002 | 12743700 | 2 | Schizoaffective disorder |
| 127437002 | 12743700 | 3 | Adenocarcinoma of colon |
| 127437002 | 12743700 | 4 | Adenocarcinoma of colon |
| 127437002 | 12743700 | 5 | Premedication |
| 127437002 | 12743700 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127437002 | 12743700 | OT |
| 127437002 | 12743700 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127437002 | 12743700 | Acute kidney injury | |
| 127437002 | 12743700 | Capillary leak syndrome | |
| 127437002 | 12743700 | Diarrhoea | |
| 127437002 | 12743700 | Nausea | |
| 127437002 | 12743700 | Nephrogenic diabetes insipidus | |
| 127437002 | 12743700 | Pulmonary oedema | |
| 127437002 | 12743700 | Temperature intolerance |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |