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The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.
Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least three complete blood count (CBC) values must be available for the 12 weeks prior to study registration for patients with MDS and chronic iron overload from blood transfusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICL670 | Experimental | Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferasirox | Drug | 20 mg/kg/day over one year in patients with MDS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Adverse Events | Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the study, whether or not considered related to the participant's participation in the study. Serious Adverse Events include adverse events that result in either of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. | up to 53 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Ferritin From Baseline to Weeks 13, 25, 37 and 53 | Change in levels of serum ferritin from baseline to 3, 6, 9 and 12 months (Weeks 13, 25, 37 and 53). | From Baseline to Weeks 13, 25, 37 and 53 |
| Change in Labile Plasma Iron (LPI) |
Not provided
Inclusion Criteria:
For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year.
Serum ferritin ≥ 1000 ng/mL at screening via the central lab.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22547607 | Result | List AF, Baer MR, Steensma DP, Raza A, Esposito J, Martinez-Lopez N, Paley C, Feigert J, Besa E. Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome. J Clin Oncol. 2012 Jun 10;30(17):2134-9. doi: 10.1200/JCO.2010.34.1222. Epub 2012 Apr 30. |
| Label | URL |
|---|---|
| Results for CICL670AUS03 from the Novartis Clinical Trials website | View source |
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A total of 176 participants enrolled in the study, of these 173 participants were treated. Three of the enrolled participants were not treated as 2 withdrew the consent and 1 died even before initiating the treatment.
Of the 173 treated participants, 95 completed the study and 78 discontinued treatment prematurely.
The study was conducted at 39 centers in the United States and 6 centers in Canada
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| ID | Title | Description |
|---|---|---|
| FG000 | Deferasirox | Participants received Deferasirox 20 Milligrams per Kilogram per day (mg/kg/day) orally once per day (OD) for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The blood sample for LPI determinations was collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. LPI was calculated as 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe
| From Baseline to Weeks 13, 25, 37 and 49 |
| Directly Chelatable Iron (DCI) | The blood sample for DCI determinations were collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. | From Baseline to Weeks 13, 25, 37 and 49 |
| Total Iron Levels | Levels of non-transferrin bound iron (NTBI) and serum iron from baseline to 3,6,9 and 12 months (Weeks 13, 25, 37 and 49) were assessed. | From Baseline to Weeks 13, 25, 37, 49 and 53 |
| Serum Transferrin Levels | Serum transferrin from baseline to 3, 6, 9 and 12 months of treatment (Visit Weeks 13, 25, 37 and 49) were assessed. | From Baseline to Weeks 13, 25, 37, 49 and 53 |
| Transferrin Saturation | Levels of transferrin saturation from baseline to 3, 6, 9 and 12 months. | From Baseline to Weeks 13, 25, 37, 49 and 53 |
| Transfusion Requirements | Number of participants receiving transfusions, the summarized during the study. | up to 1 year |
| Frequency of Hematologic Improvement During the Study | Hematologic responses defined by International Working Group response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks defined as: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets: absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence. | up to 1 year |
| Trough Plasma Deferasirox Concentration | The Pharmacokinetic (PK) parameters were assessed at Week 13, 25, 37 and 49 using Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) method. | At Week 13, 25, 37 and 49 |
| Treatment Compliance to Deferasirox | Treatment compliance was assessed using records of study medication used, dosages administered, and intervals between visits during the study. Drug accountability was noted by the field monitor during site visits and at the completion of the trial. Participants were asked to return all unused medication at monthly visits. | up to 1 year |
| The Prevalence of Hereditary Hemochromatosis Gene (HFE) Gene Mutations | HFE (hemochromatosis) gene mutations in the Myelodysplastic Syndrome (MDS) population, the trial included testing for the C282Y, H63D and S65C HFE gene mutations. One blood sample was collected at Baseline (Week 1), or, if that visit was missing, the sample was taken at Week 13 (Month 3). Only one blood sample was to be taken from each participant. | up to Week 13 (Month 3) |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Bay Area Cancer Research Group | Concord | California | 94520 | United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| Cedars-Sinai Medical Center, UCLA School of Medicine | Los Angeles | California | 90048 | United States |
| UCLA Medical Center | Los Angeles | California | 90095-1678 | United States |
| UCSF | San Francisco | California | 94143-0324 | United States |
| UCSF | San Francisco | California | 94143 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Emory University School of Medicine/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60612 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637-1470 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky College of Medicine, Markey Cancer Center | Lexington | Kentucky | 40536-0093 | United States |
| Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital | Alexandria | Louisiana | 71301 | United States |
| St. Agnes HealthCare | Baltimore | Maryland | 21231-1000 | United States |
| Rush Cancer Institute Univ. of Massachussets Medical Center | Worcester | Massachusetts | 01605 | United States |
| Novartis Investigative Site | Southfield | Michigan | 48075 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| The Center for Cancer Care & Research (TCCCR) | St Louis | Missouri | 63110 | United States |
| Oncology Hematology West, PC | Omaha | Nebraska | 68124-2346 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | United States |
| The Cancer Center at Hackensack University | Hackensack | New Jersey | 07601 | United States |
| NMOHC | Albuquerque | New Mexico | 87109 | United States |
| Roswell Park Cancer Center | Buffalo | New York | 14623 | United States |
| Rochester General Hospital/Lipson Cancer and Blood Center | Rochester | New York | 14621 | United States |
| Cancer Care of WNC | Asheville | North Carolina | 28801 | United States |
| Wake Forest UniversitComprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1082 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Novartis Investigative Site | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer Center | Philadelphia | Pennsylvania | 19107 | United States |
| Western Pennsylvania Hospital Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| The West Cancer Clinic | Memphis | Tennessee | 38120 | United States |
| Novartis Investigative site | Nashville | Tennessee | 37232 | United States |
| Baylor/The Methodist Hospital | Houston | Texas | 77030 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Arlington Fairfax Hematology Oncology PC | Arlington | Virginia | 22205 | United States |
| Novartis Investigative Site | Spokane | Washington | 99202 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Novartis Investigative Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Novartis Investigative Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M4N 3M5 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5g 2M9 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Publication (Embasse # 2012421150) | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) population consisted of all participants who received at least 1 dose of Deferasirox.
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| ID | Title | Description |
|---|---|---|
| BG000 | Deferasirox | Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Adverse Events | Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the study, whether or not considered related to the participant's participation in the study. Serious Adverse Events include adverse events that result in either of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. | The safety population consisted of all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | up to 53 Weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change in Serum Ferritin From Baseline to Weeks 13, 25, 37 and 53 | Change in levels of serum ferritin from baseline to 3, 6, 9 and 12 months (Weeks 13, 25, 37 and 53). | The Full Analysis Set (FAS) populations consisted of all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | μg/L | From Baseline to Weeks 13, 25, 37 and 53 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Labile Plasma Iron (LPI) | LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The blood sample for LPI determinations was collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. LPI was calculated as 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe | The full analysis set populations consisted of all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | LPI Unit | From Baseline to Weeks 13, 25, 37 and 49 |
|
| ||||||||||||||||||||||||||
| Secondary | Directly Chelatable Iron (DCI) | The blood sample for DCI determinations were collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. | The full analysis set populations consisted of all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | µM | From Baseline to Weeks 13, 25, 37 and 49 |
|
| ||||||||||||||||||||||||||
| Secondary | Total Iron Levels | Levels of non-transferrin bound iron (NTBI) and serum iron from baseline to 3,6,9 and 12 months (Weeks 13, 25, 37 and 49) were assessed. | The full analysis set populations consisted of all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | μg/dL | From Baseline to Weeks 13, 25, 37, 49 and 53 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Transferrin Levels | Serum transferrin from baseline to 3, 6, 9 and 12 months of treatment (Visit Weeks 13, 25, 37 and 49) were assessed. | The full analysis set populations consisted of all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | mg/dL | From Baseline to Weeks 13, 25, 37, 49 and 53 |
|
| ||||||||||||||||||||||||||
| Secondary | Transferrin Saturation | Levels of transferrin saturation from baseline to 3, 6, 9 and 12 months. | The full analysis set populations consisted of all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | percentage of saturation | From Baseline to Weeks 13, 25, 37, 49 and 53 |
|
| ||||||||||||||||||||||||||
| Secondary | Transfusion Requirements | Number of participants receiving transfusions, the summarized during the study. | The full analysis set populations consisted of all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | up to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Frequency of Hematologic Improvement During the Study | Hematologic responses defined by International Working Group response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks defined as: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets: absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence. | The analysis was performed on Per protocol population defined as number of participants who did not present any major deviations from protocol and received at least one dose of study drug. | Posted | Count of Participants | Participants | up to 1 year |
| ||||||||||||||||||||||||||||
| Secondary | Trough Plasma Deferasirox Concentration | The Pharmacokinetic (PK) parameters were assessed at Week 13, 25, 37 and 49 using Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) method. | The full analysis set populations consisted of all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | μmol/L | At Week 13, 25, 37 and 49 |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Compliance to Deferasirox | Treatment compliance was assessed using records of study medication used, dosages administered, and intervals between visits during the study. Drug accountability was noted by the field monitor during site visits and at the completion of the trial. Participants were asked to return all unused medication at monthly visits. | The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment. | Posted | Number | participants | up to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | The Prevalence of Hereditary Hemochromatosis Gene (HFE) Gene Mutations | HFE (hemochromatosis) gene mutations in the Myelodysplastic Syndrome (MDS) population, the trial included testing for the C282Y, H63D and S65C HFE gene mutations. One blood sample was collected at Baseline (Week 1), or, if that visit was missing, the sample was taken at Week 13 (Month 3). Only one blood sample was to be taken from each participant. | The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment. | Posted | Count of Participants | Participants | up to Week 13 (Month 3) |
|
|
All Adverse Event Were Collected From Start of Treatment up to 53 Weeks
Out of 176 participants enrolled in the study, 173 participants received study medication. As, two participants withdrew consent and one died before initiating the treatment, were not considered for this analysis.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deferasirox | Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed. | 17 | 173 | 78 | 173 | 166 | 173 |
| EG001 | Enrolled, Not Treated | Participant died before initiating the treatment. | 1 | 3 | 0 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Concomitant disease progression | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Induration | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Clostridium bacteraemia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Propionibacterium infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Haemochromatosis | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D019190 | Iron Overload |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| D002614 | Chelating Agents |
| D003676 | Deferoxamine |
| D007502 | Iron Chelating Agents |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D064449 | Sequestering Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D006880 | Hydroxy Acids |
Not provided
Not provided
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| Other |
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