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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 77417715 | 7741771 | 5 | F | 20160711 | 20101228 | 20160725 | EXP | IT-CELGENEUS-083-21880-10122365 | CELGENE | MAURO F, CARELLA A, VIGNETTI M, ORLANDO S, LIBERATI A, MOLICA S. FLUDARABINE, CYCLOPHOSPHAMIDE AND LENALIDOMIDE IN RELAPSED/REFRACTORY PATIENTS WITH CLL, RESULTS OF THE PHASE1-2 GIMEMA STUDY LLC606. HEMATOLOGICA CONFERENCE: 45 CONGRESS OF THE ITALIAN SOCIETY OF HEMATOLOGY FLORENCE ITALY. 2015 OCT 21;100:79. | 0.00 | E | Y | 0.00000 | 20160725 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 77417715 | 7741771 | 1 | PS | REVLIMID | LENALIDOMIDE | 1 | Oral | U | U | 21880 | CAPSULES | ||||||||
| 77417715 | 7741771 | 2 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | U | U | 21880 | CAPSULES | ||||||||
| 77417715 | 7741771 | 3 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | 30 MILLIGRAM/SQ. METER | U | U | 21880 | CAPSULES | |||||||
| 77417715 | 7741771 | 4 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | 250 MILLIGRAM/SQ. METER | U | U | 21880 | CAPSULES | |||||||
| 77417715 | 7741771 | 5 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | U | U | 21880 | 5 | MG | CAPSULES | ||||||
| 77417715 | 7741771 | 6 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | U | U | 21880 | 10 | MG | CAPSULES | ||||||
| 77417715 | 7741771 | 7 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous drip | U | U | 60100 | UNKNOWN | ||||||||
| 77417715 | 7741771 | 8 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | U | 0 | UNKNOWN | ||||||||
| 77417715 | 7741771 | 9 | C | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 77417715 | 7741771 | 10 | C | ENOXAPARIN | ENOXAPARIN | 1 | Subcutaneous | 4000 UNITS | 0 | UNKNOWN | |||||||||
| 77417715 | 7741771 | 11 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 300 MILLIGRAM | 0 | UNKNOWN | |||||||||
| 77417715 | 7741771 | 12 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 77417715 | 7741771 | 1 | Chronic lymphocytic leukaemia |
| 77417715 | 7741771 | 7 | Chronic lymphocytic leukaemia |
| 77417715 | 7741771 | 8 | Chronic lymphocytic leukaemia |
| 77417715 | 7741771 | 9 | Prophylaxis |
| 77417715 | 7741771 | 10 | Thrombosis prophylaxis |
| 77417715 | 7741771 | 11 | Prophylaxis |
| 77417715 | 7741771 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 77417715 | 7741771 | OT |
| 77417715 | 7741771 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 77417715 | 7741771 | Anaemia | |
| 77417715 | 7741771 | Chronic lymphocytic leukaemia | |
| 77417715 | 7741771 | Constipation | |
| 77417715 | 7741771 | Fatigue | |
| 77417715 | 7741771 | Granulocytopenia | |
| 77417715 | 7741771 | Hypertransaminasaemia | |
| 77417715 | 7741771 | Liver disorder | |
| 77417715 | 7741771 | Muscle spasms | |
| 77417715 | 7741771 | Neutropenia | |
| 77417715 | 7741771 | Pneumonia | |
| 77417715 | 7741771 | Pneumonitis | |
| 77417715 | 7741771 | Pyrexia | |
| 77417715 | 7741771 | Rash | |
| 77417715 | 7741771 | Richter's syndrome | |
| 77417715 | 7741771 | Thrombocytopenia | |
| 77417715 | 7741771 | Treatment failure | |
| 77417715 | 7741771 | Tumour flare | |
| 77417715 | 7741771 | Tumour lysis syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |