Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6810136 | 7406814 | F | 6810136-3 | 20100510 | 20100616 | 20100630 | EXP | DE-GENZYME-CLOF-1000983 | GENZYMEP | 60 | YR | F | Y | 59 | KG | 20100630 | MD | 20100601 | GERMANY |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6810136 | 1014006332 | PS | EVOLTRA | 2 | INTRAVENOUS | 63 MG, QDX5 | A446133H11 AND A451386H28 | 21673 | |||
| 6810136 | 1014006333 | SS | ARA-C | 2 | INTRAVENOUS | 1000 MG/M2, QDX5 | |||||
| 6810136 | 1014006334 | C | DEXTROSE | 1 | UNKNOWN | 1000 ML, UNK | |||||
| 6810136 | 1014006335 | C | SODIUM CHLORIDE | 1 | UNKNOWN | 1000 ML, QD | |||||
| 6810136 | 1014006336 | C | POTASSIUM CHLORIDE | 1 | UNKNOWN | 1000 ML, QD | |||||
| 6810136 | 1014006337 | C | FORTECORTIN | 2 | UNKNOWN | 8 MG, UNK | |||||
| 6810136 | 1014006338 | C | KEVATRIL | 2 | UNKNOWN | 1 MG, UNK |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6810136 | 1014006332 | ACUTE MYELOID LEUKAEMIA |
| 6810136 | 1014006333 | ACUTE MYELOID LEUKAEMIA |
| 6810136 | 1014006334 | DRUG USE FOR UNKNOWN INDICATION |
| 6810136 | 1014006335 | DRUG USE FOR UNKNOWN INDICATION |
| 6810136 | 1014006336 | DRUG USE FOR UNKNOWN INDICATION |
| 6810136 | 1014006337 | DRUG USE FOR UNKNOWN INDICATION |
| 6810136 | 1014006338 | DRUG USE FOR UNKNOWN INDICATION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6810136 | DE |
| 6810136 | LT |
| 6810136 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 6810136 | ACCIDENTAL OVERDOSE |
| 6810136 | ACUTE HEPATIC FAILURE |
| 6810136 | ACUTE MYELOID LEUKAEMIA RECURRENT |
| 6810136 | ANURIA |
| 6810136 | APNOEA |
| 6810136 | ASCITES |
| 6810136 | BLISTER |
| 6810136 | BLOOD PRESSURE SYSTOLIC INCREASED |
| 6810136 | BRONCHOALVEOLAR LAVAGE ABNORMAL |
| 6810136 | CAPILLARY LEAK SYNDROME |
| 6810136 | CARDIAC FAILURE |
| 6810136 | CARDIOTOXICITY |
| 6810136 | DEPRESSED LEVEL OF CONSCIOUSNESS |
| 6810136 | DIALYSIS |
| 6810136 | DRUG TOXICITY |
| 6810136 | ELECTROCARDIOGRAM QT PROLONGED |
| 6810136 | ENTEROCOCCAL BACTERAEMIA |
| 6810136 | FLUID RETENTION |
| 6810136 | GASTROINTESTINAL SOUNDS ABNORMAL |
| 6810136 | HAEMOGLOBIN DECREASED |
| 6810136 | HANGOVER |
| 6810136 | HEPATIC CONGESTION |
| 6810136 | HEPATIC ENCEPHALOPATHY |
| 6810136 | HEPATIC VEIN DILATATION |
| 6810136 | HEPATOMEGALY |
| 6810136 | HEPATOTOXICITY |
| 6810136 | LUNG DISORDER |
| 6810136 | METABOLIC ACIDOSIS |
| 6810136 | METABOLIC ENCEPHALOPATHY |
| 6810136 | MITRAL VALVE INCOMPETENCE |
| 6810136 | NEUTROPENIA |
| 6810136 | OVERDOSE |
| 6810136 | PAIN |
| 6810136 | PLEURAL EFFUSION |
| 6810136 | PNEUMONIA |
| 6810136 | PNEUMONIA PRIMARY ATYPICAL |
| 6810136 | RENAL FAILURE ACUTE |
| 6810136 | RENAL INFARCT |
| 6810136 | SEPSIS |
| 6810136 | SIMPLEX VIRUS TEST POSITIVE |
| 6810136 | SKIN TOXICITY |
| 6810136 | SOMNOLENCE |
| 6810136 | STAPHYLOCOCCAL BACTERAEMIA |
| 6810136 | STEM CELL TRANSPLANT |
| 6810136 | SYSTEMIC INFLAMMATORY RESPONSE SYNDROME |
| 6810136 | THROMBOCYTOPENIA |
| 6810136 | TOXIC ENCEPHALOPATHY |
| 6810136 | TREATMENT FAILURE |
| 6810136 | WHITE BLOOD CELL COUNT DECREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6810136 | 1014006332 | 20100507 | 20100511 | 5 | DAY |
| 6810136 | 1014006333 | 20100507 | 20100511 | 5 | DAY |
| 6810136 | 1014006334 | 20100507 | 20100513 | 7 | DAY |
| 6810136 | 1014006335 | 20100507 | 20100513 | 7 | DAY |
| 6810136 | 1014006336 | 20100507 | 20100512 | 6 | DAY |
| 6810136 | 1014006337 | 20100507 | 20100513 | 7 | DAY |
| 6810136 | 1014006338 | 20100507 | 20100513 | 7 | DAY |