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Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke (ASSENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02586233
Recruitment Status : Completed
First Posted : October 26, 2015
Results First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Acute Ischemic Stroke
Thrombotic Disease
Interventions Drug: DS-1040b
Drug: Placebo
Enrollment 106
Recruitment Details A total of 106 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at a total of 78 clinic sites (46 in Europe, 19 in the United States, 7 in Asia, 5 in Australia, and 1 in Canada). Of the 106 participants randomized, 101 participants received treatment.
Pre-assignment Details The study consisted of 6, sequential, ascending-dose cohorts. Participants were randomized to either DS-1040b or placebo in a 3:1 ratio.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg Placebo
Hide Arm/Group Description Participants who received a single intravenous infusion of DS-1040b 0.6 mg. Participants who received a single intravenous infusion of DS-1040b 1.2 mg. Participants who received a single intravenous infusion of DS-1040b 2.4 mg. Participants who received a single intravenous infusion of DS-1040b 4.8 mg. Participants who received a single intravenous infusion of DS-1040b 7.2 mg. Participants who received a single intravenous infusion of DS-1040b 9.6 mg. Participants who received a single intravenous infusion of placebo.
Period Title: Overall Study
Started 7 7 13 17 18 18 26
Completed 7 5 13 17 16 16 24
Not Completed 0 2 0 0 2 2 2
Reason Not Completed
Randomized but did not receive treatment             0             1             0             0             0             2             2
Death             0             1             0             0             2             0             0
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg Placebo Total
Hide Arm/Group Description Participants who received a single intravenous infusion of DS-1040b 0.6 mg. Participants who received a single intravenous infusion of DS-1040b 1.2 mg. Participants who received a single intravenous infusion of DS-1040b 2.4 mg. Participants who received a single intravenous infusion of DS-1040b 4.8 mg. Participants who received a single intravenous infusion of DS-1040b 7.2 mg. Participants who received a single intravenous infusion of DS-1040b 9.6 mg. Participants who received a single intravenous infusion of placebo. Total of all reporting groups
Overall Number of Baseline Participants 7 6 13 17 18 16 24 101
Hide Baseline Analysis Population Description
Demographics and baseline characteristics were assessed in the Safety Analysis Set.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants 15 participants 17 participants 16 participants 23 participants 95 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  33.3%
3
  50.0%
8
  66.7%
8
  53.3%
9
  52.9%
9
  56.3%
13
  56.5%
52
  54.7%
>=65 years
4
  66.7%
3
  50.0%
4
  33.3%
7
  46.7%
8
  47.1%
7
  43.8%
10
  43.5%
43
  45.3%
[1]
Measure Analysis Population Description: Age data were missing for participants in some cohorts.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants 15 participants 17 participants 16 participants 23 participants 95 participants
68.2  (7.8) 68.2  (10.2) 62.7  (9.7) 69.1  (11.1) 65.8  (11.7) 64.8  (12.8) 62.2  (12.3) 65.2  (11.4)
[1]
Measure Analysis Population Description: Age data were missing for participants in some cohorts.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants 17 participants 18 participants 16 participants 24 participants 101 participants
Female
3
  42.9%
2
  33.3%
5
  38.5%
6
  35.3%
8
  44.4%
6
  37.5%
11
  45.8%
41
  40.6%
Male
4
  57.1%
4
  66.7%
8
  61.5%
11
  64.7%
10
  55.6%
10
  62.5%
13
  54.2%
60
  59.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants 17 participants 18 participants 16 participants 24 participants 101 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
4
  23.5%
8
  44.4%
2
  12.5%
3
  12.5%
17
  16.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
1
  16.7%
1
   7.7%
2
  11.8%
0
   0.0%
1
   6.3%
4
  16.7%
10
   9.9%
White
6
  85.7%
4
  66.7%
11
  84.6%
11
  64.7%
10
  55.6%
13
  81.3%
17
  70.8%
72
  71.3%
More than one race
0
   0.0%
1
  16.7%
1
   7.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Summary of Treatment-Emergent Adverse Event Reported by >10% of Participants Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Hide Description Treatment-emergent adverse event (TEAE) is defined as an adverse event that emerges during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at predose; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-dose state, when the adverse event is continuous.
Time Frame Baseline up to 90 days post last dose, up to 3 years 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment-emergent adverse events were assessed in the Safety Analysis Set.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg All DS-1040b Placebo
Hide Arm/Group Description:
Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
All participants who received a single intravenous infusion of DS-1040b.
Participants who received a single intravenous infusion of placebo.
Overall Number of Participants Analyzed 7 6 13 17 18 16 77 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
5
  71.4%
5
  83.3%
10
  76.9%
15
  88.2%
14
  77.8%
14
  87.5%
63
  81.8%
18
  75.0%
Hypokalaemia
1
  14.3%
2
  33.3%
2
  15.4%
0
   0.0%
2
  11.1%
2
  12.5%
9
  11.7%
6
  25.0%
Constipation
1
  14.3%
2
  33.3%
3
  23.1%
1
   5.9%
5
  27.8%
2
  12.5%
14
  18.2%
5
  20.8%
Insomnia
0
   0.0%
0
   0.0%
1
   7.7%
0
   0.0%
1
   5.6%
3
  18.8%
5
   6.5%
5
  20.8%
Hypertension
0
   0.0%
0
   0.0%
1
   7.7%
3
  17.6%
1
   5.6%
0
   0.0%
5
   6.5%
3
  12.5%
Anxiety
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
  12.5%
3
   3.9%
3
  12.5%
Hyperglycaemia
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
1
   5.6%
0
   0.0%
2
   2.6%
3
  12.5%
Dyslipidaemia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
1
   6.3%
2
   2.6%
3
  12.5%
Thrombocytopenia
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.3%
3
  12.5%
Vomiting
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.3%
3
  12.5%
Pyrexia
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.3%
3
  12.5%
Vitamin B12 deficiency
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  12.5%
Headache
3
  42.9%
1
  16.7%
2
  15.4%
2
  11.8%
1
   5.6%
4
  25.0%
13
  16.9%
2
   8.3%
2.Secondary Outcome
Title Summary of Pharmacokinetic (PK) Parameter Maximum (Peak) Observed Plasma Concentration (Cmax) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Hide Description The PK parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) of DS-1040b was calculated from the plasma concentrations of DS-1040b using non-compartmental analysis
Time Frame Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg
Hide Arm/Group Description:
Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
Overall Number of Participants Analyzed 5 6 13 16 17 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
10.09  (3.26) 26.95  (9.39) 61.28  (35.67) 729.76  (1661.06) 191.06  (59.60) 203.70  (41.49)
3.Secondary Outcome
Title Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration Sampling Point (AUClast) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Hide Description The PK parameter of Area Under the Concentration Versus Time Curve from Zero to Last Quantifiable Concentration Sampling Point of DS-1040b was calculated from the plasma concentrations of DS-1040b using non-compartmental analysis
Time Frame Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg
Hide Arm/Group Description:
Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
Overall Number of Participants Analyzed 5 6 13 16 17 10
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
69.74  (16.19) 219.83  (95.16) 447.75  (199.97) 2611.87  (4471.65) 1489.21  (460.78) 1700.24  (346.43)
4.Secondary Outcome
Title Summary of Pharmacokinetic Parameter Terminal Half-life (t1/2) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Hide Description The PK parameter of Terminal Half-life of DS-1040b was calculated from the plasma concentrations of DS-1040b using non-compartmental analysis in patients with available sample for the analysis.
Time Frame Pre-dose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set, except for terminal half-life which was assessed in patients with available sample for the analysis.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg
Hide Arm/Group Description:
Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
Overall Number of Participants Analyzed 4 2 7 8 14 8
Mean (Standard Deviation)
Unit of Measure: h
2.59  (0.46) 4.14  (0.17) 10.50  (15.02) 36.68  (25.94) 33.37  (14.71) 35.86  (10.98)
5.Secondary Outcome
Title Summary of Activated Form of Thrombin-activatable Fibrinolysis Inhibitor (TAFIa) Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Hide Description The enzymatic activity of thrombin-activatable fibrinolysis inhibitor was assessed using the Stago Coagulation Analyzer.
Time Frame Baseline and 6 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
TAFIa activity was assessed in the Pharmacodynamic Analysis Set.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg (Non-IAT) Placebo
Hide Arm/Group Description:
Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
Participants who received a single intravenous infusion of DS-1040b 9.6 mg (non-intra-arterial thrombectomy).
Participants who received a single intravenous infusion of placebo.
Overall Number of Participants Analyzed 7 6 13 17 18 10 24
Mean (Standard Deviation)
Unit of Measure: mean percentage of TAFIa activity
Baseline Number Analyzed 7 participants 5 participants 13 participants 16 participants 17 participants 9 participants 19 participants
96.7  (23.7) 97.8  (17.5) 100.4  (21.6) 105.1  (23.4) 108.1  (30.5) 112.6  (27.2) 100.9  (20.8)
6 h postdose Number Analyzed 6 participants 6 participants 10 participants 16 participants 17 participants 9 participants 21 participants
93.5  (26.6) 98.8  (27.2) 86.7  (16.7) 75.9  (20.9) 72.9  (22.6) 73.9  (14.4) 104.1  (24.7)
6.Secondary Outcome
Title Summary of Changes From Baseline at Day 30 in National Institute of Health Stroke Scale (NIHSS) Score Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Hide Description The National Institute of Health Stroke Scale (NIHSS) quantifies stroke severity based on weighted evaluation findings. The score for each ability is a number between 0 and 4, with 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score indicates more impairment (worse outcome) in a stroke patient.
Time Frame 30 days post dose
Hide Outcome Measure Data
Hide Analysis Population Description
NIHSS stroke scale scores were assessed in the Safety Analysis Set.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg All DS-1040b Placebo
Hide Arm/Group Description:
Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
All participants who received a single intravenous infusion of DS-1040b.
Participants who received a single intravenous infusion of placebo.
Overall Number of Participants Analyzed 7 6 13 17 18 16 77 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.7  (2.21) -3.0  (2.00) -3.5  (1.71) -2.06  (1.06) -3.4  (2.70) -6.2  (3.08) -3.9  (2.56) -3.6  (4.27)
7.Secondary Outcome
Title Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 to 2 Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Hide Description The modified Rankin scale (mRS) is a commonly used disability scale derived from the Rankin scale that is used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The level of disability following a stroke is assessed via a scale from 0 to 6, where 0 is no symptoms at all and 6 indicates death. Higher scores indicate worse outcome. The percentage of participants with an mRS score of 0 to 2 at Day 5 (baseline) and Day 90 is being reported.
Time Frame Day 5 (baseline) and Day 90 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Rankin scale scores were assessed in the Safety Analysis Set.
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg All DS-1040b Placebo
Hide Arm/Group Description:
Participants who received a single intravenous infusion of DS-1040b 0.6 mg.
Participants who received a single intravenous infusion of DS-1040b 1.2 mg.
Participants who received a single intravenous infusion of DS-1040b 2.4 mg.
Participants who received a single intravenous infusion of DS-1040b 4.8 mg.
Participants who received a single intravenous infusion of DS-1040b 7.2 mg.
Participants who received a single intravenous infusion of DS-1040b 9.6 mg.
All participants who received a single intravenous infusion of DS-1040b.
Participants who received a single intravenous infusion of placebo.
Overall Number of Participants Analyzed 7 6 13 17 18 16 77 24
Measure Type: Number
Unit of Measure: percentage of participants
Day 5 Number Analyzed 6 participants 5 participants 13 participants 17 participants 18 participants 15 participants 74 participants 24 participants
66.7 40.0 76.9 82.4 72.2 53.3 68.9 54.2
Day 90 Number Analyzed 7 participants 5 participants 13 participants 17 participants 16 participants 16 participants 74 participants 24 participants
85.7 60.0 76.9 82.4 93.8 68.8 79.7 75.0
Time Frame Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 3 years 11 months.
Adverse Event Reporting Description A TEAE is defined as an adverse event that: emerges during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at predose; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-dose state, when the adverse event is continuous.
 
Arm/Group Title Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg All DS-1040b Placebo
Hide Arm/Group Description Participants who received a single intravenous infusion of DS-1040b 0.6 mg. Participants who received a single intravenous infusion of DS-1040b 1.2 mg. Participants who received a single intravenous infusion of DS-1040b 2.4 mg. Participants who received a single intravenous infusion of DS-1040b 4.8 mg. Participants who received a single intravenous infusion of DS-1040b 7.2 mg. Participants who received a single intravenous infusion of DS-1040b 9.6 mg. All participants who received a single intravenous infusion of DS-1040b. Participants who received a single intravenous infusion of placebo.
All-Cause Mortality
Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg All DS-1040b Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   1/6 (16.67%)   0/13 (0.00%)   0/17 (0.00%)   2/18 (11.11%)   0/16 (0.00%)   3/77 (3.90%)   0/24 (0.00%) 
Hide Serious Adverse Events
Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg All DS-1040b Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)   4/6 (66.67%)   0/13 (0.00%)   1/17 (5.88%)   2/18 (11.11%)   2/16 (12.50%)   10/77 (12.99%)   4/24 (16.67%) 
Cardiac disorders                 
Cardiac arrest  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Hepatobiliary disorders                 
Cholestasis  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hepatocellular injury  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Infections and infestations                 
Escherichia urinary tract infection  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Pneumonia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Urosepsis  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Nervous system disorders                 
Carotid arteriosclerosis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Carotid artery stenosis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Haemorrhage intracranial  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Simple partial seizures  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Cerebrovascular accident  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  1/24 (4.17%) 
Spinal cord infarction  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  1/24 (4.17%) 
Psychiatric disorders                 
Agitation  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Renal and urinary disorders                 
Renal failure acute  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Pulmonary embolism  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  1/24 (4.17%) 
Vascular disorders                 
Haematoma  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: DS-1040b 0.6 mg Cohort 2: DS-1040b 1.2 mg Cohort 3: DS-1040b 2.4 mg Cohort 4: DS-1040b 4.8 mg Cohort 5: DS-1040b 7.2 mg Cohort 6: DS-1040b 9.6 mg All DS-1040b Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   5/6 (83.33%)   10/13 (76.92%)   15/17 (88.24%)   14/18 (77.78%)   14/16 (87.50%)   63/77 (81.82%)   18/24 (75.00%) 
Blood and lymphatic system disorders                 
Anaemia  1  0/7 (0.00%)  1/6 (16.67%)  2/13 (15.38%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  4/77 (5.19%)  2/24 (8.33%) 
Hyperfibrinogenaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Thrombocytopenia  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  3/24 (12.50%) 
Leukocytosis  1  1/7 (14.29%)  1/6 (16.67%)  1/13 (7.69%)  1/17 (5.88%)  2/18 (11.11%)  0/16 (0.00%)  6/77 (7.79%)  2/24 (8.33%) 
Cardiac disorders                 
Atrial fibrillation  1  1/7 (14.29%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  1/18 (5.56%)  1/16 (6.25%)  4/77 (5.19%)  1/24 (4.17%) 
Cardiac arrest  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Sinus tachycardia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Tachycardia  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Bradycardia  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  2/77 (2.60%)  0/24 (0.00%) 
Left ventricular dysfunction  1  1/7 (14.29%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Ventricular extrasystoles  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Eye disorders                 
Conjunctival haemorrhage  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Dry eye  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Vision blurred  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain upper  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Dyspepsia  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Diarrhoea  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  2/16 (12.50%)  2/77 (2.60%)  1/24 (4.17%) 
Dysphagia  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  2/77 (2.60%)  1/24 (4.17%) 
Constipation  1  1/7 (14.29%)  2/6 (33.33%)  3/13 (23.08%)  1/17 (5.88%)  5/18 (27.78%)  2/16 (12.50%)  14/77 (18.18%)  5/24 (20.83%) 
Toothache  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Vomiting  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  3/24 (12.50%) 
Nausea  1  0/7 (0.00%)  0/6 (0.00%)  2/13 (15.38%)  2/17 (11.76%)  0/18 (0.00%)  2/16 (12.50%)  6/77 (7.79%)  2/24 (8.33%) 
General disorders                 
Fatigue  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  1/16 (6.25%)  4/77 (5.19%)  0/24 (0.00%) 
Asthenia  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Chest discomfort  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Chest pain  1  0/7 (0.00%)  1/6 (16.67%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Inflammation  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Influenza-like illness  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Infusion-site phlebitis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Peripheral swelling  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Pyrexia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  3/24 (12.50%) 
Vessel puncture site pain  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Pain  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Hepatobiliary disorders                 
Cholestasis  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hepatocellular injury  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Infections and infestations                 
Bacterial disease carrier  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Bronchitis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Pneumonia  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  2/18 (11.11%)  1/16 (6.25%)  4/77 (5.19%)  1/24 (4.17%) 
Clostridium difficile colitis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Conjunctivitis bacterial  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Escherichia urinary tract infection  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hepatitis B  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Postoperative wound infection  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Pyuria  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Respiratory tract infection  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Urosepsis  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Urinary tract infection  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  2/17 (11.76%)  3/18 (16.67%)  1/16 (6.25%)  6/77 (7.79%)  1/24 (4.17%) 
Nasopharyngitis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Upper respiratory tract infection  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  2/18 (11.11%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Injury, poisoning and procedural complications                 
Fall  1  1/7 (14.29%)  0/6 (0.00%)  1/13 (7.69%)  1/17 (5.88%)  0/18 (0.00%)  1/16 (6.25%)  4/77 (5.19%)  1/24 (4.17%) 
Joint injury  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Post-procedural haematuria  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Wound  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Investigations                 
Biopsy bone  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Blood albumin decreased  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Blood creatinine increased  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Activated partial thromboplastin time prolonged  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  2/24 (8.33%) 
Blood bicarbonate decreased  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  2/24 (8.33%) 
Blood fibrinogen increased  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  2/24 (8.33%) 
Blood glucose increased  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Body temperature increased  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Ejection fraction decreased  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Electrocardiogram QT prolonged  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Red blood cell sedimentation rate increased  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Vitamin D decreased  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Metabolism and nutrition disorders                 
Diabetes mellitus  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hypocalcaemia  1  1/7 (14.29%)  1/6 (16.67%)  2/13 (15.38%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  4/77 (5.19%)  2/24 (8.33%) 
Electrolyte imbalance  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Fluid imbalance  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hyperlipidaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  1/24 (4.17%) 
Hyperuricaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hypoalbuminaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  2/24 (8.33%) 
Hypoglycaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Dyslipidaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  1/16 (6.25%)  2/77 (2.60%)  3/24 (12.50%) 
Hyperglycaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  0/16 (0.00%)  2/77 (2.60%)  3/24 (12.50%) 
Hypercholesterolaemia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  2/16 (12.50%)  3/77 (3.90%)  0/24 (0.00%) 
Hyperchloraemia  1  0/7 (0.00%)  1/6 (16.67%)  4/13 (30.77%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  5/77 (6.49%)  2/24 (8.33%) 
Hypokalaemia  1  1/7 (14.29%)  2/6 (33.33%)  2/13 (15.38%)  0/17 (0.00%)  2/18 (11.11%)  2/16 (12.50%)  9/77 (11.69%)  6/24 (25.00%) 
Hypomagnesaemia  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Vitamin D deficiency  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Vitamin B12 deficiency  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  3/24 (12.50%) 
Hyponatraemia  1  1/7 (14.29%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  3/77 (3.90%)  2/24 (8.33%) 
Malnutrition  1  0/7 (0.00%)  1/6 (16.67%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  3/77 (3.90%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthritis  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Muscle spasms  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Musculoskeletal pain  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  2/24 (8.33%) 
Back pain  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  2/77 (2.60%)  1/24 (4.17%) 
Muscular weakness  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  2/17 (11.76%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  1/24 (4.17%) 
Arthralgia  1  0/7 (0.00%)  0/6 (0.00%)  2/13 (15.38%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  3/77 (3.90%)  2/24 (8.33%) 
Osteoarthritis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Tendonitis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Tenosynovitis  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Muscle spasticity  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Neurological decompensation  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Neurological symptom  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Paraesthesia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Nervous system disorders                 
Burning sensation  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Carotid arteriosclerosis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Carotid artery stenosis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Carpal tunnel syndrome  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Cerebral haemorrhage  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Circadian rhythm sleep disorder  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Dizziness  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  1/24 (4.17%) 
Dysaesthesia  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Cerebrovascular accident  1  1/7 (14.29%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  1/24 (4.17%) 
Haemorrhage intracranial  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  1/24 (4.17%) 
Haemorrhagic stroke  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Partial seizures  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Sedation  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Simple partial seizures  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Somnolence  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Memory impairment  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Psychomotor hyperactivity  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  1/17 (5.88%)  0/18 (0.00%)  1/16 (6.25%)  3/77 (3.90%)  0/24 (0.00%) 
Headache  1  3/7 (42.86%)  1/6 (16.67%)  2/13 (15.38%)  2/17 (11.76%)  1/18 (5.56%)  4/16 (25.00%)  13/77 (16.88%)  2/24 (8.33%) 
Stroke in evolution  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Syncope  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Psychiatric disorders                 
Affective disorder  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hallucination  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Mood altered  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Confusional state  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  1/16 (6.25%)  2/77 (2.60%)  0/24 (0.00%) 
Depressed mood  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Depression  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  2/24 (8.33%) 
Delirium  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  2/24 (8.33%) 
Agitation  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  1/16 (6.25%)  3/77 (3.90%)  0/24 (0.00%) 
Anxiety  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  2/16 (12.50%)  3/77 (3.90%)  3/24 (12.50%) 
Insomnia  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  1/18 (5.56%)  3/16 (18.75%)  5/77 (6.49%)  5/24 (20.83%) 
Sleep disorder  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Renal and urinary disorders                 
Dysuria  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Glycosuria  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Neurogenic bladder  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Urethral pain  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Urinary incontinence  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Haematuria  1  0/7 (0.00%)  1/6 (16.67%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  2/24 (8.33%) 
Renal failure acute  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  2/16 (12.50%)  2/77 (2.60%)  0/24 (0.00%) 
Urinary retention  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  1/16 (6.25%)  2/77 (2.60%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Bronchiectasis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Dyspnoea  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Hypoxia  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Nasal obstruction  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Oropharyngeal pain  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Productive cough  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Pulmonary mass  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/77 (1.30%)  0/24 (0.00%) 
Cough  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  2/18 (11.11%)  0/16 (0.00%)  3/77 (3.90%)  1/24 (4.17%) 
Pulmonary oedema  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Respiratory failure  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  1/18 (5.56%)  1/16 (6.25%)  2/77 (2.60%)  0/24 (0.00%) 
Rhinorrhoea  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders                 
Angioedema  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Psoriasis  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Erythema  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Petechiae  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  1/18 (5.56%)  0/16 (0.00%)  2/77 (2.60%)  0/24 (0.00%) 
Decubitis ulcer  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  0/77 (0.00%)  2/24 (8.33%) 
Swelling face  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Vascular disorders                 
Arteriosclerosis  1  1/7 (14.29%)  0/6 (0.00%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  0/24 (0.00%) 
Hypotension  1  0/7 (0.00%)  1/6 (16.67%)  0/13 (0.00%)  0/17 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/77 (1.30%)  1/24 (4.17%) 
Haematoma  1  0/7 (0.00%)  0/6 (0.00%)  0/13 (0.00%)  1/17 (5.88%)  0/18 (0.00%)  1/16 (6.25%)  2/77 (2.60%)  0/24 (0.00%) 
Hypertension  1  0/7 (0.00%)  0/6 (0.00%)  1/13 (7.69%)  3/17 (17.65%)  1/18 (5.56%)  0/16 (0.00%)  5/77 (6.49%)  3/24 (12.50%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02586233    
Other Study ID Numbers: DS1040-A-U103
2015-001824-43 ( EudraCT Number )
First Submitted: October 21, 2015
First Posted: October 26, 2015
Results First Submitted: July 10, 2020
Results First Posted: September 9, 2020
Last Update Posted: September 9, 2020