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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006977-34 | EudraCT Number | ||
| U1111-1187-6569 | Registry Identifier | WHO |
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This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS). This study looked at the antitumor activity in people who received alisertib.
The study enrolled 57 patients. Participants were categorized by disease sub-types AML and MDS. Participants received:
• Alisertib 50 mg
All participants took alisertib capsules every 12 hours each day for 7 days followed by a 14-day rest period in 21-day cycles for approximately 26 cycles.
This multi-center trial was conducted in North America and France. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. The participant could continue treatment beyond 12 months if it was considered by the Sponsor and the Investigator that they would derive benefit from continued alisertib treatment. Participants had weekly blood work and clinic visits, with disease assessments every 2 cycles (ie. every 6 weeks) up to and including Cycle 16. Reduced visits (every 12 weeks) were conducted for participants tolerating treatment beyond Cycle 16 and for participants off treatment without disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisertib | Experimental | Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisertib | Drug | Alisertib capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate (ORR) Based on Investigator's Assessment | Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils >1x10^9/L, platelets >100x10^9/L, bone marrow blasts(BMB) <5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB <5%, transfusion independent, no EMD; PR=neutrophils >1x10^9/L, platelets >100x10^9/L, BMB >50% decrease and 5% to 25%, blasts <5% with Auer rods; PRi=BMB >50% decrease and 5% to 25%. MDS:CR=bone marrow: ≤5% myeloblasts with normal maturation, peripheral blood: hemoglobin ≥11 g/dL, platelets ≥100x10^9/L, neutrophils ≥1.0x10^9/L, blasts 0%; PR=all CR criteria if abnormal before treatment except: BMB decreased by ≥50% over pretreatment but still >5%; PRi=BMB decreased by ≥50% over pretreatment but still >5%; Marrow CR=bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment, peripheral blood hematologic improvement responses noted. | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time from the date of first study drug administration to the date of first documented progressive disease (PD) or death. | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
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Inclusion Criteria:
Each participants must meet all of the following inclusion criteria:
Male or female participants 18 years or older
Eligible diagnoses:
Eastern Cooperative Oncology Group performance status 0-2
Female participants:
Male participants:
Voluntary written consent
Participants on hydroxyurea may be included
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology and Oncology Associates of Northern New Jersey | Morristown | New Jersey | 07962 | United States |
Participants with a diagnosis of acute myelogenous leukemia or myelodysplastic syndrome received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are reported according to lymphoma disease subtypes: acute myelogenous leukemia and myelodysplastic syndrome.
Participants took part in the study at 19 investigative sites in France, Canada and the United States from 10 February 2009 to 04 July 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisertib 50 mg (Acute Myeloid Leukemia) | Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). |
| FG001 | Alisertib 50 mg (Myelodysplastic Syndrome) | Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population was defined as all participants who received any amount of alisertib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alisertib 50 mg (Acute Myeloid Leukemia) | Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). |
| BG001 |
| 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 | Best Overall Response Rate (ORR) Based on Investigator's Assessment | Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils >1x10^9/L, platelets >100x10^9/L, bone marrow blasts(BMB) <5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB <5%, transfusion independent, no EMD; PR=neutrophils >1x10^9/L, platelets >100x10^9/L, BMB >50% decrease and 5% to 25%, blasts <5% with Auer rods; PRi=BMB >50% decrease and 5% to 25%. MDS:CR=bone marrow: ≤5% myeloblasts with normal maturation, peripheral blood: hemoglobin ≥11 g/dL, platelets ≥100x10^9/L, neutrophils ≥1.0x10^9/L, blasts 0%; PR=all CR criteria if abnormal before treatment except: BMB decreased by ≥50% over pretreatment but still >5%; PRi=BMB decreased by ≥50% over pretreatment but still >5%; Marrow CR=bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment, peripheral blood hematologic improvement responses noted. | Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. In 2 participants disease transformed from MDS to AML. One participant is considered AML and one participant is considered MDS in the calculation, based on the timing of their transformation. | Posted | Number | participants | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
First dose of study drug to 30 days after last dose (Up to 18.9 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 | Alisertib 50 mg (Acute Myeloid Leukemia) | Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C550258 | MLN 8237 |
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| Duration of Response (DOR) | Duration of response is defined as the time from the date of first documentation of a response to the date of first documented PD. | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
| Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment | Best overall HI response is defined as percentage of participants with response as assessed by Investigator based on IWG criteria: 1)Erythroid response (pretreatment,<11 g/dL): hemoglobin (Hgb) increase by ≥1.5 g/dL, relevant reduction of units of red blood cell (RBC) transfusions by absolute number of at least 4 RBC transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks. Only RBC transfusions given for Hgb of ≤9.0 g/dL pretreatment will count in RBC transfusion response evaluation. 2)Platelet response (pretreatment,<100x10^9/L):Absolute increase of ≥30x10^9/L for participants starting->20x10^9/L platelets, increase <20x10^9/L to >20x10^9/L by at least 100%. 3)Neutrophil response (pretreatment,<1.0x10^9/L):At least 100% increase and an absolute increase >0.5x10^9/L. 4)Progression or relapse after HI:At least 1 of following: 50% decrement from maximum response levels in granulocytes or platelets, or reduction in Hgb by ≥1.5 g/dL, or transfusion dependence. | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator. | First dose of study drug to 30 days after last dose (Up to 18.9 months) |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | Vital signs measurements (blood pressure, heart rate, and oral temperature) were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | First dose of study drug to 30 days after last dose (Up to 18.9 months) |
| Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | Abnormal Laboratory Values for Chemistry or Hematology tests that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. A treatment--emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | First dose of study drug to 30 days after last dose (Up to 18.9 months) |
| Adverse Event |
|
| Withdrawal by Patient |
|
| Reason not Specified |
|
| Alisertib 50 mg (Myelodysplastic Syndrome) |
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Baseline height data is available for n=36,10 participants, respectively. | Mean | Standard Deviation | cm |
|
| Weight | Baseline weight data is available for n=45,11 participants, respectively. | Mean | Standard Deviation | kg |
|
| Baseline Body Surface Area (BSA) | Baseline BSA data is available for n=36,10 participants, respectively. | Mean | Standard Deviation | m^2 |
|
| Years Since Initial Diagnosis | Mean | Standard Deviation | years |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance is defined as: 0=Normal activity (fully active, able to carry on all predisease performance without restriction); 1=Symptoms but ambulatory (restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature); 2=In bed <50% of the time (ambulatory and capable of all self-care, but unable to carry out any work activities. | Number | participants |
|
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from the date of first study drug administration to the date of first documented progressive disease (PD) or death. | Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better. | Posted | Median | 95% Confidence Interval | days | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
|
|
|
| Secondary | Duration of Response (DOR) | Duration of response is defined as the time from the date of first documentation of a response to the date of first documented PD. | Response--Evaluable Population included all participants who had measurable disease, received at least 1 dose of alisertib, and had at least 1 post baseline response assessment. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better. | Posted | Median | 95% Confidence Interval | days | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
|
|
|
| Secondary | Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment | Best overall HI response is defined as percentage of participants with response as assessed by Investigator based on IWG criteria: 1)Erythroid response (pretreatment,<11 g/dL): hemoglobin (Hgb) increase by ≥1.5 g/dL, relevant reduction of units of red blood cell (RBC) transfusions by absolute number of at least 4 RBC transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks. Only RBC transfusions given for Hgb of ≤9.0 g/dL pretreatment will count in RBC transfusion response evaluation. 2)Platelet response (pretreatment,<100x10^9/L):Absolute increase of ≥30x10^9/L for participants starting->20x10^9/L platelets, increase <20x10^9/L to >20x10^9/L by at least 100%. 3)Neutrophil response (pretreatment,<1.0x10^9/L):At least 100% increase and an absolute increase >0.5x10^9/L. 4)Progression or relapse after HI:At least 1 of following: 50% decrement from maximum response levels in granulocytes or platelets, or reduction in Hgb by ≥1.5 g/dL, or transfusion dependence. | Safety population was defined as all participants who received any amount of alisertib. | Posted | Number | percentage of participants | Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator. | Safety population was defined as all participants who received any amount of alisertib. | Posted | Number | participants | First dose of study drug to 30 days after last dose (Up to 18.9 months) |
|
|
|
| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | Vital signs measurements (blood pressure, heart rate, and oral temperature) were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety population was defined as all participants who received any amount of alisertib. | Posted | Number | participants | First dose of study drug to 30 days after last dose (Up to 18.9 months) |
|
|
|
| Secondary | Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | Abnormal Laboratory Values for Chemistry or Hematology tests that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. A treatment--emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety population was defined as all participants who received any amount of alisertib. | Posted | Number | participants | First dose of study drug to 30 days after last dose (Up to 18.9 months) |
|
|
|
| 36 |
| 46 |
| 45 |
| 46 |
| EG001 | Alisertib 50 mg (Myelodysplastic Syndrome) | Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles). | 8 | 11 | 11 | 11 |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Serratia bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Subdural hygroma | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Title | Measurements |
|---|---|
|
| Progression or Relapse |
|
| Not Available |
|
| Unable to Assess |
|
| Deaths |
|
| Hypotension |
|
| Atrial fibrillation |
|
| Tachycardia |
|
| Dyspnoea exertional |
|
| Hypertension |
|
| Supraventricular tachycardia |
|
| Weight decreased |
|
| Tachypnoea |
|
| Hyperthermia |
|
| Hypothermia |
|
| Bradycardia |
|
| Ventricular tachycardia |
|
| Thrombocytopenia |
|
| Neutropenia |
|
| Leukopenia |
|
| Hypoalbuminaemia |
|
| Leukocytosis |
|
| Hypokalaemia |
|
| Hyponatraemia |
|
| Neutrophil count decreased |
|
| Hypocalcaemia |
|
| Clostridium difficile colitis |
|
| Febrile bone marrow aplasia |
|
| Hypoxia |
|
| Hyperkalaemia |
|
| Hypernatraemia |
|
| Hyperglycaemia |
|
| Hypoglycaemia |
|
| Hypomagnesaemia |
|
| Hypophospataemia |
|
| Alanine aminotransferase increased |
|
| Blood bilirubin increased |
|
| Oxygen saturation decreased |
|
| Blood culture positive |
|
| Blood magnesium decreased |
|
| Blood creatinine increased |
|
| White blood cell count decreased |
|
| Gilbert's syndrome |
|
| Lymphoedema |
|
| Platelet count decreased |
|