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| ID | Type | Description | Link |
|---|---|---|---|
| CP17-0801 | Other Identifier | ImClone, LLC | |
| I5C-IE-JEBA | Other Identifier | Eli Lilly and Company |
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Lack of efficacy
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The purpose of this study is to determine if IMC-EB10 is safe for participants with leukemia, and also to determine the best dose of IMC-EB10 to give to participants.
The purpose of this study is to define the maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of the anti-FMS-like tyrosine kinase 3 (FLT3) monoclonal antibody IMC-EB10, administered weekly in participant with acute lymphoblastic leukemia (AML) who have failed to achieve complete remission to a standard induction regimen, relapsed after response to previous antileukemia therapy, or are not eligible for potentially curative or approved salvage options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-EB10 5 milligrams/kilogram (mg/kg) | Experimental | All participants will receive intravenous infusions of IMC-EB10, with the dose depending on which cohort they are enrolled into. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-EB10 | Biological | Cohort 1 will receive IMC-EB10 intravenously for 3 weekly infusions, followed by a 1-week observation period. The starting dose in Cohort 1 will be 5 mg/kg. After all participants in Cohort 1 complete the first cycle of therapy, dose escalation for subsequent cohorts will proceed as follows: Cohort 2 - 10 mg/kg, Cohort 3 - 20 mg/kg, Cohort 4 - 30 mg/kg. Participants who experience a dose-limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Participants may continue to receive IMC-EB10 therapy, in the absence of treatment failure, treatment intolerance, or other withdrawal criteria for additional 28-day cycles at the same dose that they initially received. Dosing for Cycle 2 and beyond will be administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerate Dose (MTD) of IMC-EB10 | MTD is defined as the dose preceding the dose level at which 2 participants experienced a dose limiting toxicity (DLT) during Cycle 1. DLT is defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v 3.0): (1) any Grade 3 or 4 toxicity that is clearly not attributable to leukemia [for example (e.g.) a type of end-organ failure that is infrequently encountered in acute myeloid leukemia (AML)] and is possibly, probably, or definitely attributable to IMC-EB10 in the judgment of the investigator; and (2) any Grade 3 or 4 toxicity that is clearly not attributable to a co-medication (e.g., prolonged neutropenia that is not attributable to hydroxyurea). | Cycle 1 (28-day cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK): Maximum Concentration (Cmax) | Cycle 1 Week 1: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 96, and 168 h after infusion ends, and Cycle 1 Week 3: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycles) | |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Concentration [AUC(0-last)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E-mail: ClinicalTrials@ ImClone.com | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Columbus | Ohio | 43210 | United States | ||
| ImClone Investigational Site |
Participant Flow is reporting enrolled participants who discontinued from the study. Participants who died or had progressive disease (PD) were considered to have completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - 5mg/kg IMC-EB10 (LY3012218) | IMC-EB10: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| FG001 | Cohort 2 - 10 mg/kg IMC-EB10 | IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| FG002 | Cohort 3 - 20 mg/kg IMC-EB10 | IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| FG003 | Cohort 4 - 30 mg/kg IMC-EB10 | IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - 5mg/kg IMC-EB10 | IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| BG001 | Cohort 2 - 10 mg/kg IMC-EB10 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Tolerate Dose (MTD) of IMC-EB10 | MTD is defined as the dose preceding the dose level at which 2 participants experienced a dose limiting toxicity (DLT) during Cycle 1. DLT is defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v 3.0): (1) any Grade 3 or 4 toxicity that is clearly not attributable to leukemia [for example (e.g.) a type of end-organ failure that is infrequently encountered in acute myeloid leukemia (AML)] and is possibly, probably, or definitely attributable to IMC-EB10 in the judgment of the investigator; and (2) any Grade 3 or 4 toxicity that is clearly not attributable to a co-medication (e.g., prolonged neutropenia that is not attributable to hydroxyurea). | All participants who received at least 1 dose of study drug. | Posted | Number | mg/kg | Cycle 1 (28-day cycle) |
|
Not provided
Not provided
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 | Cohort 1 - 5mg/kg IMC-EB10 | IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
Because development of IMC-EB10 was put on hold due to lack of efficacy analyses were not carried out as planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C548514 | IMC-EB10 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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|
|
| Cycle 1 Week 1: predose, immediately after infusion, and at 1.5, 2, 4, 8, 24, 96 and 168 h after infusion ends (28-day cycle) |
| PK: Area Under the Concentration Time Curve During the Dosing Interval (AUCtau) Where Tau is 168 Hours | Cycle 1 Week 3: predose, immediately after infusion and at 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycle) |
| Number of Participants With Adverse Events (AEs) (Safety Profile of IMC-EB10) | Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module | 8 weeks and 30-day post-treatment follow-up |
| Number of Participants With Anti-IMC-EB10 Antibodies | A participant is considered positive for antibodies against IMC-EB10 if their blood sample exhibited a post-treatment antibody level that exceeds the positive upper cut point determined from the anti-IMC-EB10 level in healthy untreated individuals. A participant was considered to have an anti-IMC-EB10 response if there are 2 consecutive positive samples or if the final sample tested is positive. | Cycle 1, Weeks 1 and 3 and Cycle 2, Week 1: predose (28-day cycles) |
| Number of Participants With Antileukemic Complete Response (CR) or Partial Response (PR) | Assessment of antileukemic response was based on hematologic response criteria. PR defined as >1000/microliter (µL) neutrophils and ≥100000/µL platelets in peripheral blood; a decrease of ≥50% in the pretreatment percentage of blasts to 5% to 25% in the bone marrow aspirate or a value of ≤5% blasts if Auer rods are present. Cytogenetic CR defined as normal cytogenetic findings. Molecular CR defined as negative findings for minimal residual disease by automated quantitative Reverse-Transcription-Polymerase Chain Reaction (RT-PCR) and multidimensional flow cytometry. Morphologic CR with incomplete blood count recovery defined as ≤5% blasts (containing no Auer rods) in a bone marrow aspirate with spicules; neutrophil count < 1000/µL or platelets <100000/mL in peripheral blood or no extramedullary leukemia present. | 4 weeks |
| Number of Participants With Feline McDonough Sarcoma (FMS)-Like Tyrosine Kinase 3 (FLT3) Response | FLT3 response to IMC-EB10 is defined as wild type, internal tandem duplications (ITD) mutations and other mutations. | Week 4 and Week 8 |
| Houston |
| Texas |
| 77030 |
| United States |
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
| BG002 | Cohort 3 - 20 mg/kg IMC-EB10 | IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| BG003 | Cohort 4 - 30 mg/kg IMC-EB10 | IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
|
| Secondary | Pharmacokinetic (PK): Maximum Concentration (Cmax) | All randomized participants with Cmax results. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Cycle 1 Week 1: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 96, and 168 h after infusion ends, and Cycle 1 Week 3: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycles) |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Concentration [AUC(0-last)] | All randomized participants with AUC(0-last) results. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms * hours/milliliter (µg*h/mL) | Cycle 1 Week 1: predose, immediately after infusion, and at 1.5, 2, 4, 8, 24, 96 and 168 h after infusion ends (28-day cycle) |
|
|
|
| Secondary | PK: Area Under the Concentration Time Curve During the Dosing Interval (AUCtau) Where Tau is 168 Hours | All randomized participants with AUCtau results. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg*h/mL | Cycle 1 Week 3: predose, immediately after infusion and at 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycle) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) (Safety Profile of IMC-EB10) | Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | 8 weeks and 30-day post-treatment follow-up |
|
|
|
| Secondary | Number of Participants With Anti-IMC-EB10 Antibodies | A participant is considered positive for antibodies against IMC-EB10 if their blood sample exhibited a post-treatment antibody level that exceeds the positive upper cut point determined from the anti-IMC-EB10 level in healthy untreated individuals. A participant was considered to have an anti-IMC-EB10 response if there are 2 consecutive positive samples or if the final sample tested is positive. | Zero participants were analyzed. The study was discontinued early due to lack of efficacy and no data was collected. | Posted | Cycle 1, Weeks 1 and 3 and Cycle 2, Week 1: predose (28-day cycles) |
|
|
| Secondary | Number of Participants With Antileukemic Complete Response (CR) or Partial Response (PR) | Assessment of antileukemic response was based on hematologic response criteria. PR defined as >1000/microliter (µL) neutrophils and ≥100000/µL platelets in peripheral blood; a decrease of ≥50% in the pretreatment percentage of blasts to 5% to 25% in the bone marrow aspirate or a value of ≤5% blasts if Auer rods are present. Cytogenetic CR defined as normal cytogenetic findings. Molecular CR defined as negative findings for minimal residual disease by automated quantitative Reverse-Transcription-Polymerase Chain Reaction (RT-PCR) and multidimensional flow cytometry. Morphologic CR with incomplete blood count recovery defined as ≤5% blasts (containing no Auer rods) in a bone marrow aspirate with spicules; neutrophil count < 1000/µL or platelets <100000/mL in peripheral blood or no extramedullary leukemia present. | All randomized participants who received at least 1 dose of study drug.No anti-leukemic responses were observed as there were no responders due to high rate of treatment failures and were not evaluable. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Number of Participants With Feline McDonough Sarcoma (FMS)-Like Tyrosine Kinase 3 (FLT3) Response | FLT3 response to IMC-EB10 is defined as wild type, internal tandem duplications (ITD) mutations and other mutations. | All randomized participants who received at least 1 dose of study drug. No tyrosine kinase responses were observed as there were no responders due to high rate of treatment failures and were not evaluable. | Posted | Number | participants | Week 4 and Week 8 |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2 - 10 mg/kg IMC-EB10 | IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. | 7 | 13 | 11 | 13 |
| EG002 | Cohort 3 - 20 mg/kg IMC-EB10 | IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. | 1 | 3 | 3 | 3 |
| EG003 | Cohort 4 - 30 mg/kg IMC-EB10 | IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles. | 3 | 5 | 5 | 5 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Herpes zoster disseminated | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Conjunctival pallor | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Stenotrophomonas infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemodynamic instability | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
|
| Week 3 |
|
|
| Other Non-Serious AEs |
|