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Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00807495
Recruitment Status : Completed
First Posted : December 12, 2008
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Burkitt's Lymphoma
T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma
Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component
Intervention Drug: Alisertib
Enrollment 48
Recruitment Details Participants took part in the study at 12 investigative sites in the United States from 10 February 2009 to last participant off study 13 February 2013, with a data cut-off on 04 January 2011 to report the primary endpoint.
Pre-assignment Details Participants with a diagnosis of Aggressive Non-Hodgkin’s Lymphoma received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are categorized as disease sub-types: Diffuse Large B-cell lymphoma (DLBL), Mantle Cell lymphoma (MCL), Transformed Follicular lymphoma (TFL), Burkitts lymphoma (BL) and Aggressive T-Cell lymphoma (ATL).
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Period Title: Overall Study
Started 22 13 5 1 7 [1]
Completed 14 [2] 7 1 0 2
Not Completed 8 6 4 1 5
Reason Not Completed
Adverse Event             6             3             1             1             2
Withdrawal by Patient             2             0             1             0             0
Reason Not Specified             0             3             2             0             3
[1]
An ATL participant had late on-study biopsy and was in DLBL, reducing ATL participants from 8 to 7.
[2]
Completed = participants who completed the study treatment to PD or symptomatic deterioration.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL) Total
Hide Arm/Group Description Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Total of all reporting groups
Overall Number of Baseline Participants 22 13 5 1 7 48
Hide Baseline Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 13 participants 5 participants 1 participants 7 participants 48 participants
66.8  (11.11) 67.2  (6.71) 65.2  (9.96) 76.0 [1]   (NA) 54.4  (16.90) 65.1  (11.56)
[1]
Standard deviation was not estimable as only 1 participant was analyzed in this arm group.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 13 participants 5 participants 1 participants 7 participants 48 participants
Female
9
  40.9%
1
   7.7%
3
  60.0%
0
   0.0%
0
   0.0%
13
  27.1%
Male
13
  59.1%
12
  92.3%
2
  40.0%
1
 100.0%
7
 100.0%
35
  72.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 13 participants 5 participants 1 participants 7 participants 48 participants
White 21 13 5 1 7 47
Other 1 0 0 0 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 13 participants 5 participants 1 participants 7 participants 48 participants
Hispanic or Latino 1 0 1 0 1 3
Not Hispanic or Latino 21 13 4 1 6 45
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 22 participants 13 participants 5 participants 1 participants 7 participants 48 participants
88.85  (27.022) 96.18  (25.139) 89.06  (29.724) 72.58 [1]   (NA) 84.45  (14.494) 89.88  (24.737)
[1]
Standard deviation was not estimable as only 1 participant was analyzed in this arm group.
1.Primary Outcome
Title Best Overall Response Rate Based on Investigator’s Assessment (Applying the IWG 2007 Response Criteria)
Hide Description Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).
Time Frame Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib. Efficacy analysis for the response-evaluable population is a subset of the safety population, with participants having a minimum of baseline imaging and one on-study imaging.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description:
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Overall Number of Participants Analyzed 16 13 5 1 6
Measure Type: Number
Unit of Measure: percentage of participants
25 23 40 100 50
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.
Time Frame Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. Here number of participants analyzed were participants with PD. TTP was censored at the last response assessment that was SD or better.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description:
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Overall Number of Participants Analyzed 16 13 5 1 6
Median (95% Confidence Interval)
Unit of Measure: days
84.0
(48.0 to 430.0)
139.0
(48.0 to 809.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
237.0
(46.0 to 631.0)
[1]
Median was not reached due to the low number of participants with events.
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death.
Time Frame Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. For a participant who had not progressed and had not died, PFS was censored at the last response assessment that was SD or better.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description:
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Overall Number of Participants Analyzed 16 13 5 1 6
Median (95% Confidence Interval)
Unit of Measure: days
84.0
(48.0 to 364.0)
139.0
(48.0 to 809.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
237.0
(46.0 to 631.0)
[1]
Median was not reached due to the low number of participants with events.
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007).
Time Frame Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. All responders were evaluated in this outcome measure. Participants who had not progressed, DOR was censored at last response assessment that was SD or better.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description:
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Overall Number of Participants Analyzed 4 3 2 1 3
Median (95% Confidence Interval)
Unit of Measure: days
454.0
(182.0 to 565.0)
646.0
(243.0 to 646.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
596.0
(202.0 to 596.0)
[1]
Median was not reached due to the low number of participants with events.
5.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events
Hide Description An Adverse Event (AE) is 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator).
Time Frame First dose of study drug to 30 days after last dose (Up to 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description:
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Overall Number of Participants Analyzed 22 13 5 1 7
Measure Type: Number
Unit of Measure: participants
22 13 5 1 7
6.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Hide Description Vital signs (blood pressure, heart rate, and oral temperature) measurements 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.
Time Frame First dose of study drug to 30 days after last dose (Up to 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description:
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Overall Number of Participants Analyzed 22 13 5 1 7
Measure Type: Number
Unit of Measure: participants
Pyrexia 7 0 0 0 2
Hypotension 6 1 1 0 1
Weight decreased 2 1 0 0 1
Tachycardia 1 0 0 0 2
Hypertension 1 0 0 0 0
Bradycardia 1 0 0 0 0
Cardiac flutter 1 0 0 0 0
7.Secondary Outcome
Title Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Hide Description Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame First dose of study drug to 30 days after last dose (Up to 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description:
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
Overall Number of Participants Analyzed 22 13 5 1 7
Measure Type: Number
Unit of Measure: participants
Thrombocytopenia 11 5 3 1 5
Alanine aminotransferase increased 6 0 0 0 1
Aspartate aminotransferase increased 6 0 0 0 1
Blood alkaline phosphatase increased 6 0 0 0 1
Hypokalaemia 3 0 1 0 1
Blood lactate dehydrogenase increased 3 0 0 0 1
Blood creatinine increased 0 0 0 0 2
Blood potassium decreased 1 0 0 0 1
Lymphopenia 1 0 0 0 1
Blood urea increased 1 0 0 0 0
Hypercalcaemia 0 0 0 0 1
Hypernatraemia 0 0 0 0 1
Hypophosphataemia 0 0 0 0 1
Mean cell volume increased 0 0 0 0 1
Urine colour abnormal 0 1 0 0 0
Neutropenia 13 9 3 1 4
Time Frame First dose of study drug to 30 days after last dose (Up to 25 Months)
Adverse Event Reporting Description The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Hide Arm/Group Description Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months). Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
All-Cause Mortality
Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/22 (72.73%)   4/13 (30.77%)   5/5 (100.00%)   0/1 (0.00%)   4/7 (57.14%) 
Blood and lymphatic system disorders           
Febrile Neutropenia  1  6/22 (27.27%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Neutropenia  1  3/22 (13.64%)  2/13 (15.38%)  1/5 (20.00%)  0/1 (0.00%)  1/7 (14.29%) 
Anaemia  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Pancytopenia  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Haemolytic anaemia  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Thrombocytopenia  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Cardiac disorders           
Cardiac failure  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Acute myocardial infarction  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Atrial fibrillation  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders           
Stomatitis  1  4/22 (18.18%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Colitis ischaemic  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Abdominal pain upper  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Constipation  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Dysphagia  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Nausea  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
General disorders           
Asthenia  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Pyrexia  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Multi-organ failure  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Mucosal haemorrhage  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Death  2  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Infections and infestations           
Pneumonia  1  3/22 (13.64%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Urinary tract infection  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Cellulitis  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Osteomyelitis  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Oropharyngeal candidiasis  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Escherichia bacteraemia  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Sepsis  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Oral candidiasis  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Investigations           
Ejection fraction decreased  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders           
Rhabdomyolysis  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Lymphoma  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Myelodysplastic syndrome  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Nervous system disorders           
Carotid artery stenosis  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Balance disorder  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Encephalopathy  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Psychiatric disorders           
Confusional state  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hallucination, visual  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders           
Urinary retention  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Renal failure acute  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Calculus ureteric  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Respiratory failure  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders           
Palmar-plantar erythrodysaesthesia syndrome  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
2
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alisertib 50 mg BID Starting Dose (DLBL) Alisertib 50 mg BID Starting Dose (MCL) Alisertib 50 mg BID Starting Dose (TFL) Alisertib 50 mg BID Starting Dose (BL) Alisertib 50 mg BID Starting Dose (ATL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/22 (100.00%)   13/13 (100.00%)   5/5 (100.00%)   1/1 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders           
Neutropenia  1  16/22 (72.73%)  9/13 (69.23%)  4/5 (80.00%)  1/1 (100.00%)  4/7 (57.14%) 
Anaemia  1  15/22 (68.18%)  7/13 (53.85%)  3/5 (60.00%)  1/1 (100.00%)  5/7 (71.43%) 
Leukopenia  1  13/22 (59.09%)  8/13 (61.54%)  3/5 (60.00%)  1/1 (100.00%)  4/7 (57.14%) 
Thrombocytopenia  1  10/22 (45.45%)  5/13 (38.46%)  3/5 (60.00%)  1/1 (100.00%)  5/7 (71.43%) 
Lymphopenia  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Pancytopenia  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Splenomegaly  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Cardiac disorders           
Tachycardia  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Atrial fibrillation  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Cardiac failure congestive  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Right ventricular hypertrophy  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Ear and labyrinth disorders           
Tinnitus  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Eye disorders           
Vision blurred  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Lacrimation increased  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Night blindness  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Conjunctivitis  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders           
Diarrhoea  1  14/22 (63.64%)  8/13 (61.54%)  3/5 (60.00%)  1/1 (100.00%)  3/7 (42.86%) 
Stomatitis  1  7/22 (31.82%)  2/13 (15.38%)  2/5 (40.00%)  1/1 (100.00%)  3/7 (42.86%) 
Nausea  1  6/22 (27.27%)  2/13 (15.38%)  1/5 (20.00%)  0/1 (0.00%)  4/7 (57.14%) 
Vomiting  1  5/22 (22.73%)  3/13 (23.08%)  1/5 (20.00%)  0/1 (0.00%)  4/7 (57.14%) 
Abdominal pain  1  5/22 (22.73%)  2/13 (15.38%)  1/5 (20.00%)  0/1 (0.00%)  1/7 (14.29%) 
Constipation  1  6/22 (27.27%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  1/7 (14.29%) 
Dyspepsia  1  3/22 (13.64%)  2/13 (15.38%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Abdominal discomfort  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Abdominal pain upper  1  1/22 (4.55%)  2/13 (15.38%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Flatulence  1  2/22 (9.09%)  2/13 (15.38%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Dysphagia  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Ascites  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Gastrooesophageal reflux disease  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Haematochezia  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Mouth ulceration  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Oral pain  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Abdominal distension  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Epigastric discomfort  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Odynophagia  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Oesophagitis  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Swollen tongue  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
General disorders           
Fatigue  1  12/22 (54.55%)  9/13 (69.23%)  4/5 (80.00%)  0/1 (0.00%)  6/7 (85.71%) 
Asthenia  1  5/22 (22.73%)  1/13 (7.69%)  2/5 (40.00%)  0/1 (0.00%)  3/7 (42.86%) 
Oedema peripheral  1  4/22 (18.18%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  2/7 (28.57%) 
Pyrexia  1  6/22 (27.27%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Catheter site erythema  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Gait disturbance  1  0/22 (0.00%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Chills  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hepatobiliary disorders           
Hyperbilirubinaemia  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Infections and infestations           
Upper respiratory tract infection  1  2/22 (9.09%)  4/13 (30.77%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Cellulitis  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Oral candidiasis  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Urinary tract infection  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Fungal skin infection  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Herpes simplex  1  0/22 (0.00%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Localised infection  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Eye infection  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Herpes dermatitis  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Oral herpes  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Sinusitis  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Herpes zoster  1  1/22 (4.55%)  2/13 (15.38%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  1/22 (4.55%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Contusion  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Laceration  1  0/22 (0.00%)  0/13 (0.00%)  2/5 (40.00%)  0/1 (0.00%)  0/7 (0.00%) 
Muscle strain  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Tooth fracture  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  6/22 (27.27%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Aspartate aminotransferase increased  1  6/22 (27.27%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Blood alkaline phosphatase increased  1  6/22 (27.27%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Neutrophil count decreased  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  3/7 (42.86%) 
White blood cell count decreased  1  3/22 (13.64%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Haemoglobin decreased  1  4/22 (18.18%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Blood lactate dehydrogenase increased  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Weight decreased  1  2/22 (9.09%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Activated partial thromboplastin time prolonged  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Blood creatinine increased  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Blood potassium decreased  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Platelet count decreased  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Blood albumin decreased  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Blood bilirubin increased  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
International normalised ratio decreased  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
International normalised ratio increased  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Mean cell volume increased  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Urine colour abnormal  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  7/22 (31.82%)  2/13 (15.38%)  0/5 (0.00%)  1/1 (100.00%)  3/7 (42.86%) 
Dehydration  1  3/22 (13.64%)  1/13 (7.69%)  0/5 (0.00%)  1/1 (100.00%)  3/7 (42.86%) 
Hypokalaemia  1  3/22 (13.64%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hypoglycaemia  1  3/22 (13.64%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Hypomagnesaemia  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Hypoalbuminaemia  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Hypercalcaemia  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hyperuricaemia  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Hypophosphataemia  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hypernatraemia  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders           
Muscle spasms  1  1/22 (4.55%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  2/7 (28.57%) 
Musculoskeletal pain  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Pain in extremity  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Musculoskeletal chest pain  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Muscular weakness  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Myalgia  1  2/22 (9.09%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Back pain  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Nervous system disorders           
Somnolence  1  9/22 (40.91%)  4/13 (30.77%)  2/5 (40.00%)  1/1 (100.00%)  5/7 (71.43%) 
Dizziness  1  2/22 (9.09%)  2/13 (15.38%)  3/5 (60.00%)  0/1 (0.00%)  2/7 (28.57%) 
Headache  1  2/22 (9.09%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  1/7 (14.29%) 
Amnesia  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Sinus headache  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Syncope  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Tremor  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Ataxia  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Carotid artery aneurysm  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Cognitive disorder  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Dizziness postural  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Dysgeusia  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hyperreflexia  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Mental impairment  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Paraesthesia  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Restless legs syndrome  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Sedation  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Memory Impairment  1  2/22 (9.09%)  3/13 (23.08%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Psychiatric disorders           
Insomnia  1  0/22 (0.00%)  4/13 (30.77%)  0/5 (0.00%)  0/1 (0.00%)  3/7 (42.86%) 
Confusional state  1  3/22 (13.64%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Depression  1  1/22 (4.55%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  2/7 (28.57%) 
Attention deficit  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Anxiety  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders           
Nephrolithiasis  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Urinary incontinence  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  1/1 (100.00%)  0/7 (0.00%) 
Renal failure  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  4/22 (18.18%)  1/13 (7.69%)  2/5 (40.00%)  0/1 (0.00%)  2/7 (28.57%) 
Cough  1  3/22 (13.64%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Dyspnoea exertional  1  3/22 (13.64%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Oropharyngeal pain  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Pleural effusion  1  2/22 (9.09%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  1/7 (14.29%) 
Nasal congestion  1  1/22 (4.55%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Atelectasis  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Dysphonia  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Epistaxis  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Productive cough  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Pulmonary oedema  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hypoxia  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Oropharyngeal plaque  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Orthopnoea  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Rhinitis allergic  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Sinus congestion  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Tonsillar hypertrophy  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  9/22 (40.91%)  8/13 (61.54%)  4/5 (80.00%)  1/1 (100.00%)  1/7 (14.29%) 
Rash pruritic  1  1/22 (4.55%)  3/13 (23.08%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Night sweats  1  3/22 (13.64%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Pruritus  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Blister  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  2/7 (28.57%) 
Decubitus ulcer  1  1/22 (4.55%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Drug eruption  1  1/22 (4.55%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Erythema  1  1/22 (4.55%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Hyperhidrosis  1  2/22 (9.09%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Rash papular  1  1/22 (4.55%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Dermal cyst  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Dry skin  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Increased tendency to bruise  1  0/22 (0.00%)  1/13 (7.69%)  0/5 (0.00%)  0/1 (0.00%)  0/7 (0.00%) 
Petechiae  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Rash erythematous  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  1/1 (100.00%)  0/7 (0.00%) 
Skin discolouration  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Skin irritation  1  0/22 (0.00%)  0/13 (0.00%)  1/5 (20.00%)  0/1 (0.00%)  0/7 (0.00%) 
Skin lesion  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Urticaria  1  0/22 (0.00%)  0/13 (0.00%)  0/5 (0.00%)  0/1 (0.00%)  1/7 (14.29%) 
Vascular disorders           
Hypotension  1  6/22 (27.27%)  1/13 (7.69%)  1/5 (20.00%)  0/1 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00807495     History of Changes
Other Study ID Numbers: C14004
U1111-1187-1268 ( Registry Identifier: WHO )
First Submitted: December 11, 2008
First Posted: December 12, 2008
Results First Submitted: January 4, 2018
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018