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The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eculizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eculizumab | Drug | Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Complete TMA Response | Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart). | Through 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Complete Hematologic Response | Proportion of Patients with Complete Hematologic response through 26 weeks of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart. | Through 26 weeks |
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Inclusion:
Exclusion:
Any of the following was regarded as a criterion for exclusion from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta | Georgia | 30322 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33783815 | Derived | Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2. | |
| 21877169 | Derived | Tschumi S, Gugger M, Bucher BS, Riedl M, Simonetti GD. Eculizumab in atypical hemolytic uremic syndrome: long-term clinical course and histological findings. Pediatr Nephrol. 2011 Nov;26(11):2085-8. doi: 10.1007/s00467-011-1989-4. Epub 2011 Aug 30. |
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At screening, patients had to have a platelet count < lower limit of normal range (<LLN) and serum creatinine level > 97 percentile for age; and had to exhibit signs or symptoms of hemolysis at the start of the current aHUS event with fragmented RBC and a negative Coombs test.
A total of 27 patients diagnosed with aHUS signed the informed consent and of these, 22 patients were treated. Five patients were excluded from the study due to failed screening procedure and did not receive eculizumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eculizumab | Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening Period |
|
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| Proportion of Patients With Platelet Count Normalization |
Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks. |
| Through 26 weeks |
| Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement | Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart. | Through 26 weeks |
| Platelet Count Change From Baseline to 26 Weeks | Through 26 weeks |
| Proportion of Patients With Complete TMA Response | Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart). | Through End of Study, Median Exposure 55 Weeks |
| Proportion of Patients With Complete Hematologic Response | Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart. | Through End of Study, Median Exposure 55 Weeks |
| Proportion of Patients With Platelet Count Normalization | Proportion of Patients with Platelet Count Normalization through end of study was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks | Through End of Study, Median Exposure 55 Weeks |
| Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement | Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart. | Through End of Study, Median Exposure 55 Weeks |
| Platelet Count Change From Baseline to 52 Weeks | Through 52 Weeks |
| Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 5 - <10kg) N=3 | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort |
| Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 10 - <20kg) N=7 | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort |
| Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 20 - <30kg) | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort |
| Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 30 - <40kg) N=1 | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort |
| Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort ≥40kg) N=5 | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Corpus Christi | Texas | 78411 | United States |
| Spokane | Washington | 99204 | United States |
| North Adelaide | South Australia | 5006 | Australia |
| Ghent | 9000 | Belgium |
| Toronto | Ontario | M5G1X8 | Canada |
| Lille | 59800 | France |
| Marseille | 13385 | France |
| Paris | 75935 | France |
| Rouen | 76000 | France |
| Hanover | 30625 | Germany |
| Milan | Italy |
| Palermo | 90134 | Italy |
| Nijmegen | 6525 | Netherlands |
| London | United Kingdom |
| Nottingham | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period (26 Weeks) |
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| Extension Treatment Period |
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| Post Treatment Period (Patients Who Disc |
|
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The intent-to-treat (ITT) population was defined as all patients who received any amount of eculizumab, and were considered evaluable for safety and efficacy analyses. For both the efficacy and safety analyses, all 22 patients who were treated with study drug were included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Eculizumab | Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible. |
| 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 (NIH/OMB) | 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 | Proportion of Patients With Complete TMA Response | Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart). | The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 26 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Complete Hematologic Response | Proportion of Patients with Complete Hematologic response through 26 weeks of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart. | The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 26 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Platelet Count Normalization | Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks. | The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 26 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement | Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart. | The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 26 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Count Change From Baseline to 26 Weeks | Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values. | Posted | Least Squares Mean | 95% Confidence Interval | 10^9 cells/L | Through 26 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Complete TMA Response | Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart). | The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through End of Study, Median Exposure 55 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Complete Hematologic Response | Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart. | The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through End of Study, Median Exposure 55 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Platelet Count Normalization | Proportion of Patients with Platelet Count Normalization through end of study was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks | The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through End of Study, Median Exposure 55 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement | Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart. | The tabulations of the proportions of patients with eGFR Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through End of Study, Median Exposure 55 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Count Change From Baseline to 52 Weeks | Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values. | Posted | Least Squares Mean | 95% Confidence Interval | 10^9 cells/L | Through 52 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 5 - <10kg) N=3 | PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data | Posted | Mean | Standard Deviation | micrograms/mL | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort |
|
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| Secondary | Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 10 - <20kg) N=7 | PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data | Posted | Mean | Standard Deviation | micrograms/mL | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort |
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| Secondary | Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 20 - <30kg) | PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data | Posted | Mean | Standard Deviation | micrograms/mL | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort |
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| Secondary | Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 30 - <40kg) N=1 | PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data. N=0 in the maintenance phase because the patient changed to ≥40kg body weight category | Posted | Mean | Standard Deviation | micrograms/mL | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort |
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| Secondary | Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort ≥40kg) N=5 | PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data. | Posted | Mean | Standard Deviation | micrograms/mL | Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort |
|
|
Through end of study; exposure to eculizumab in this study extended for a median duration of 12.6 months and ranged from 1 dose to 24.5 months.
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eculizumab | Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible. | 13 | 22 | 20 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| BUNDLE BRANCH BLOCK RIGHT | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA Version 15.1 | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA Version 15.1 | Systematic Assessment |
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| EYE DISCHARGE | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ULCERATIVE KERATITIS | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| APPLICATION SITE ECZEMA | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| INJECTION SITE RASH | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| INJECTION SITE HAEMATOMA | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| ACUTE TONSILLITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| BETA HAEMOLYTIC STREPTOCOCCAL INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| CANDIDURIA | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS VIRAL | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| ESHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| FUNGAL INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| GENITAL CANDIDIASIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| ORAL FUNGAL INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| PATHOGEN RESISTANCE | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| SCRATCH | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| BLOOD BICARBONATE DECREASED | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| ELECTROCARDIOGRAM T WAVE INVERSION | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| ELECTROENCEPHALOGRAM ABNORMAL | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| WEIGHT INCREASED | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
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| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
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| METABOLIC DISORDER | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
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| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Systematic Assessment |
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| DEMYELINATING POLYNEUROPATHY | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| SINUS HEADACHE | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| FOOD AVERSION | Psychiatric disorders | MedDRA Version 15.1 | Systematic Assessment |
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| MOOD ALTERED | Psychiatric disorders | MedDRA Version 15.1 | Systematic Assessment |
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| CALCULUS URINARY | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PROTEINURIA | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| GLYCOSURIA | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| MICROALBUMINURIA | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| POLYURIA | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA Version 15.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| TONSILLAR HYPERTROPHY | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DERMATITIS DIAPER | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| INCREASED TENDENCY TO BRUISE | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PURPURA | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
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| HAEMATOMA | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PALLOR | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| NAIL INJURY | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| CENTRAL VENOUS CATHETER REMOVAL | Surgical and medical procedures | MedDRA Version 15.1 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA Version 15.1 | Systematic Assessment |
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Participation in this multicenter study involved a commitment to publish the data from the study in a cooperative publication prior to release of study results on an individual basis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | clinicaltrials@alxn.com | clinicaltrials@alxn.com |
| ID | Term |
|---|---|
| D065766 | Atypical Hemolytic Uremic Syndrome |
| ID | Term |
|---|---|
| D006463 | Hemolytic-Uremic Syndrome |
| D014511 | Uremia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C481642 | eculizumab |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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