Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1187-6760 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat participants who have advanced solid tumors or lymphomas. This study looked at mass balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib.
The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B. Participants received:
Participants were asked to take a single dose of [^14C]-alisertib oral solution containing 80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally, twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in Part B.
This single center trial was conducted in United States. The overall time to participate in this study was up to 117 days. Participants remained confined to clinic in Part A and made multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up assessment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisertib | Experimental | Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, 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 3 Cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [^14C]-alisertib | Drug | [^14C]-alisertib oral solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution | Predose and multiple timepoints post-dose (up to 240 hours) | |
| Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution | Predose and multiple timepoints post-dose (up to 240 hours) | |
| AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution | Predose and multiple timepoints post-dose (up to 240 hours) | |
| AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution | Predose and multiple timepoints post-dose (up to 240 hours) | |
| T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution | Predose and multiple timepoints post-dose (up to 240 hours) | |
| CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution | Predose and multiple timepoints post-dose (up to 240 hours) | |
| Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax | Predose and multiple timepoints post-dose (up to 240 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution | Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants. | Predose and multiple timepoints post-dose (0 to 192 hours) |
| Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution |
Not provided
Inclusion Criteria:
Each participants must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Development | Tacoma | Washington | 98418 | United States |
Participants with a diagnosis of advanced solid tumors or lymphomas received [^14C]-alisertib 35 mg oral solution single dose in Part A and alisertib 50 mg for 7 days in 21-day cycles in Part B.
Participants took part in the study at 1 investigative site in the United States from 24 January 2013 to 14 June 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Alisertib | Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, 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 3 Cycles). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
| |||||||||||||
| Part B |
|
Safety Population included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alisertib | Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, 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 3 Cycles). |
| 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 | Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution | Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | nanomole (nmol)/liter (L) | Predose and multiple timepoints post-dose (up to 240 hours) |
|
From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)
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.
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 | Alisertib | Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, 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 3 Cycles). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C550258 | MLN 8237 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| alisertib | Drug | Alisertib enteric coated tablets |
|
|
| Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax | Predose and multiple timepoints post-dose (up to 240 hours) |
| Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast | Predose and multiple timepoints post-dose (up to 240 hours) |
| Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast | Predose and multiple timepoints post-dose (up to 240 hours) |
| Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞ | Predose and multiple timepoints post-dose (up to 240 hours) |
| Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞ | Predose and multiple timepoints post-dose (up to 240 hours) |
| Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine | Predose and multiple timepoints post-dose (up to 240 hours) |
| Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces | Predose and multiple timepoints post-dose (up to 240 hours) |
| Ae: Amount of [^14C]-Alisertib Excreted in Urine | Predose and multiple timepoints post-dose (up to 240 hours) |
| Ae: Amount of [^14C]-Alisertib Excreted in Feces | Predose and multiple timepoints post-dose (up to 240 hours) |
| Percent of Total Radioactivity (TRA) in Urine and Feces | Predose and multiple timepoints post-dose (up to 240 hours) |
| Fe: Fraction of Administered Dose of Alisertib Excreted in Urine | Predose and multiple timepoints post-dose (up to 240 hours) |
| Ae: Amount of Alisertib Excretion in Urine | Predose and multiple timepoints post-dose (up to 240 hours) |
| Renal Clearance (CLR) of Alisertib | Predose and multiple timepoints post-dose (up to 240 hours) |
Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants. |
| Predose and multiple timepoints post-dose (0 to 192 hours) |
| Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution | Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants. | Predose and multiple timepoints post-dose (0 to 192 hours) |
| Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug. | From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days) |
| Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs | An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline. | Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days) |
| Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements | Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant. | Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution | Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Median | Full Range | hr | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | hour (hr)*nmol/L | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | hr*nmol/L | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | hour | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | ratio | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | ratio | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | ratio | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast | PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | ratio | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞ | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | ratio | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞ | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | ratio | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | percent of dose | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | percent of dose | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ae: Amount of [^14C]-Alisertib Excreted in Urine | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | nanogram equivalent [ng(eq)] | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ae: Amount of [^14C]-Alisertib Excreted in Feces | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | ng(eq) | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Percent of Total Radioactivity (TRA) in Urine and Feces | PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Mean | Standard Deviation | percent of TRA | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Fe: Fraction of Administered Dose of Alisertib Excreted in Urine | Participant from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Fe. | Posted | Mean | Standard Deviation | percent of dose | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Ae: Amount of Alisertib Excretion in Urine | Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Ae. | Posted | Mean | Standard Deviation | ng | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Primary | Renal Clearance (CLR) of Alisertib | Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data for CLR. | Posted | Mean | Standard Deviation | L/hr | Predose and multiple timepoints post-dose (up to 240 hours) |
|
|
|
| Secondary | Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution | Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants. | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Number | percent of plasma AUC0-192hr | Predose and multiple timepoints post-dose (0 to 192 hours) |
|
|
|
| Secondary | Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution | Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants. | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Number | percent of dose | Predose and multiple timepoints post-dose (0 to 192 hours) |
|
|
|
| Secondary | Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution | Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants. | PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance. | Posted | Number | percent of dose | Predose and multiple timepoints post-dose (0 to 192 hours) |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events | An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug. | Safety Population included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs | An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline. | Safety Population included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements | Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days) |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Scrotal swelling | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | 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.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| M536 |
|
| M1 |
|
| M8 |
|
| Others |
|
| Title | Measurements |
|---|
|
| M550 |
|
| M537 |
|
| M520b |
|
| M3 |
|
| M520c |
|
| Alisertib |
|
| M2 |
|
| Others |
|
| Title | Measurements |
|---|---|
|