Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy
Sponsor
Daiichi Sankyo Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03198715
Collaborator
(none)
42
20
5
29.7
2.1
0.1
Study Details
Study Description
Brief Summary
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
42 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Phase I, Single Blind, Placebo-controlled, Randomized Study to Assess the Safety of DS-1040b in Subjects With Thrombectomy Treated Acute Ischemic Stroke.
Actual Study Start Date
:
Jul 30, 2017
Actual Primary Completion Date
:
Jan 19, 2020
Actual Study Completion Date
:
Jan 19, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DS-1040b 0.6 mg Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours |
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Names:
|
| Experimental: DS-1040b 1.2 mg Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours |
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Names:
|
| Experimental: DS-1040b 2.4 mg Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours |
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Names:
|
| Experimental: DS-1040b 4.8 mg Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours |
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Names:
|
| Placebo Comparator: Placebo Participants receive saline by intravenous infusion over six hours |
Drug: Placebo
Saline solution for intravenous infusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants [From start of treatment up to 36 hours post single, intravenous dose]
Symptomatic and asymptomatic intracranial hemorrhage (ICH) confirmed by head imaging (CT or MRI) are reported. Symptomatic ICH was defined as Intracranial hemorrhage with clinical deterioration causing an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 4 points (defined by European Cooperative Acute Stroke Study). Asymptomatic ICH included the following: Hemorrhagic infarction type 1: Small petechial hemorrhage along the margins of the infarct, Hemorrhagic infarction type 2: Confluent petechial hemorrhage within the infarcted area, but without a mass effect, Parenchymal hematoma type 1: Hematoma involving ≤ 30% of the infarcted area with a slight mass effect, Parenchymal hematoma type 2: Hematoma involving > 30% of, or outside the infarcted area, with a significant mass effect.
- Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants [From start of treatment up to 96 hours post single, intravenous dose]
Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin.
Secondary Outcome Measures
- Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma [Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose]
The pharmacokinetic (PK) parameter of area under the plasma concentration-time curve up to the last quantifiable time was calculated using linear up logarithmic down rule.
- Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma [Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose]
The PK parameter of maximum concentration (Cmax) was observed values.
- Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma [Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose]
The PK parameter of time to maximum concentration (Tmax) was observed values. When there are more than one time point, the time point when the concentration reached the first Cmax will be used as Tmax.
- Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma [Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose]
The PK parameter of terminal half-life (T1/2) was calculated from the following formula in participants whose Kel could be calculated. T1/2=ln2 / Kel
- Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants [From start of treatment up to 24 hours post single, intravenous dose]
The pharmacokinetic parameter of amount of drug excreted in urine was calculated from the following formula: urine concentration (ng/mL) /10^6× (urine weight / urinary specific gravity)
- Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants [Baseline, 6 hours and 24 hours post single, intravenous dose]
The mean thrombin activatable fibrinolysis (TAFI) antigen levels and change from baseline in TAFI levels are reported. Change from baseline is based on the number of participants with baseline and at least one post-baseline laboratory test.
- Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants [Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose]
Mean D-dimer levels and change from baseline in D-dimer levels are reported.Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
- Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants [Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose]
Mean activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) and change from baseline in TAFIa are reported. Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Is an acute ischemic stroke patients with evidence of intracranial vascular occlusion
-
Is enrolled in principle within 8 hours of symptom onset
-
Has treatment plan that includes stent retriever
-
Has protocol-defined scores on several scales
Exclusion Criteria:
-
Has treatment plan that includes fibrinolysis or fibinolysis
-
Has identified intracranial hemorrhage or subarachnoid hemorrhage
-
Has active bleeding like gastrointestinal hemorrhage
-
Has cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
-
Has severe hepatic or renal impairment
-
Has been a participant in other clinical trial within 30 days prior to treatment
-
Is pregnant, lactating, or planning on becoming pregnant during treatment period
-
Has any condition or history that might, per protocol or in the opinion of the investigator, compromise:
-
safety or well-being of the participant or their offspring
-
safety of the study staff
-
analysis of results
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hirosaki University Hospital | Hirosaki | Aomori | Japan | 036-8563 |
| 2 | Funabashi Municipal Medical Center | Funabashi | Chiba | Japan | 273-8588 |
| 3 | Kokura Memorial Hospital | Kitakyushu | Fukuota | Japan | 802-8555 |
| 4 | Mihara Memorial Hospital | Isesaki | Gunma | Japan | 372-0006 |
| 5 | Nakamura Memorial Hospital | Sapporo | Hokkaido | Japan | 060-8570 |
| 6 | Japan Organization of Occupational Health and Safety Kansai Rosai Hospital | Amagasaki | Hyogo | Japan | 660-8511 |
| 7 | Kobe City Medical Center General Hospital | Kobe | Hyogo | Japan | 650-0046 |
| 8 | Hyogo College of Medicine College Hospital | Nishinomiya | Hyogo | Japan | 663-8501 |
| 9 | University of Tsukuba Hospital | Tsukuba | Ibaraki | Japan | 305-8576 |
| 10 | Iwate Prefectural Central Hospital | Morioka | Iwate | Japan | 020-0066 |
| 11 | Seisho Hospital | Odawara | Kanagawa | Japan | 250-0001 |
| 12 | Yokohama Municipal Citizen's Hospital | Yokohama | Kanagawa | Japan | 240-8555 |
| 13 | Mie University Hospital | Tsu | Mie | Japan | 514-8507 |
| 14 | National Cerebral and Cardiovascular Center | Suita | Osaka | Japan | 565-8565 |
| 15 | Saitama Medical University International Medical Center | Hidaka | Saitama | Japan | 350-1298 |
| 16 | Yamaguchi University Hospital | Ube | Yamaguchi | Japan | 755-8505 |
| 17 | Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Japan | 730-8518 | |
| 18 | Nagasaki University Hospital | Nagasaki | Japan | 852-8521 | |
| 19 | Niigata City General Hospital | Niigata | Japan | 950-1197 | |
| 20 | Wakayama Medical University Hospital | Wakayama | Japan | 641-8509 |
Sponsors and Collaborators
- Daiichi Sankyo Co., Ltd.
Investigators
- Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03198715
Other Study ID Numbers:
- DS1040-A-J110
- 173612
First Posted:
Jun 26, 2017
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daiichi Sankyo Co., Ltd.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 42 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment. Of the 42 participants randomized, 41 participants received treatment. |
|---|---|
| Pre-assignment Detail | The study consisted of 4 parallel, ascending-dose cohorts. The DS-1040b 0.6 mg cohort only consisted of a DS-1040b group. A ratio of DS-1040b:placebo of 3:1 per cohort was used for the 1.2 mg and higher dose cohorts. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo |
|---|---|---|---|---|---|
| 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 placebo. |
| Period Title: Overall Study | |||||
| STARTED | 6 | 12 | 12 | 3 | 9 |
| COMPLETED | 6 | 11 | 10 | 3 | 7 |
| NOT COMPLETED | 0 | 1 | 2 | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| 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 placebo. | Total of all reporting groups |
| Overall Participants | 6 | 12 | 11 | 3 | 9 | 41 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
1
16.7%
|
1
8.3%
|
2
18.2%
|
1
33.3%
|
1
11.1%
|
6
14.6%
|
| >=65 years |
5
83.3%
|
11
91.7%
|
9
81.8%
|
2
66.7%
|
8
88.9%
|
35
85.4%
|
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
71.5
(6.80)
|
76.3
(6.96)
|
73.6
(10.40)
|
69.0
(7.81)
|
76.9
(11.22)
|
74.5
(8.97)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
2
33.3%
|
5
41.7%
|
5
45.5%
|
2
66.7%
|
5
55.6%
|
19
46.3%
|
| Male |
4
66.7%
|
7
58.3%
|
6
54.5%
|
1
33.3%
|
4
44.4%
|
22
53.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
6
100%
|
12
100%
|
11
100%
|
3
100%
|
9
100%
|
41
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
6
100%
|
12
100%
|
11
100%
|
3
100%
|
9
100%
|
41
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||
| Japan |
6
100%
|
12
100%
|
11
100%
|
3
100%
|
9
100%
|
41
100%
|
Outcome Measures
| Title | Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants |
|---|---|
| Description | Symptomatic and asymptomatic intracranial hemorrhage (ICH) confirmed by head imaging (CT or MRI) are reported. Symptomatic ICH was defined as Intracranial hemorrhage with clinical deterioration causing an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 4 points (defined by European Cooperative Acute Stroke Study). Asymptomatic ICH included the following: Hemorrhagic infarction type 1: Small petechial hemorrhage along the margins of the infarct, Hemorrhagic infarction type 2: Confluent petechial hemorrhage within the infarcted area, but without a mass effect, Parenchymal hematoma type 1: Hematoma involving ≤ 30% of the infarcted area with a slight mass effect, Parenchymal hematoma type 2: Hematoma involving > 30% of, or outside the infarcted area, with a significant mass effect. |
| Time Frame | From start of treatment up to 36 hours post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Bleeding events were assessed in the Safety Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo |
|---|---|---|---|---|---|
| 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 placebo. |
| Measure Participants | 6 | 12 | 11 | 3 | 9 |
| Symptomatic ICH |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asymptomatic ICH |
2
33.3%
|
5
41.7%
|
4
36.4%
|
1
33.3%
|
1
11.1%
|
| Hemorrhagic infarction type 1 |
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
| Hemorrhagic infarction type 2 |
1
16.7%
|
1
8.3%
|
1
9.1%
|
0
0%
|
0
0%
|
| Parenchymal hematoma type 1 |
0
0%
|
3
25%
|
0
0%
|
1
33.3%
|
0
0%
|
| Parenchymal hematoma type 2 |
0
0%
|
0
0%
|
2
18.2%
|
0
0%
|
0
0%
|
| Not applicable |
1
16.7%
|
1
8.3%
|
1
9.1%
|
0
0%
|
1
11.1%
|
| Title | Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants |
|---|---|
| Description | Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin. |
| Time Frame | From start of treatment up to 96 hours post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Bleeding events were assessed in the Safety Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo |
|---|---|---|---|---|---|
| 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 placebo. |
| Measure Participants | 6 | 12 | 11 | 3 | 9 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma |
|---|---|
| Description | The pharmacokinetic (PK) parameter of area under the plasma concentration-time curve up to the last quantifiable time was calculated using linear up logarithmic down rule. |
| Time Frame | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg |
|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 11 | 10 | 3 |
| Mean (Standard Deviation) [ng*h/mL] |
111
(45.5)
|
275
(72.2)
|
570
(230)
|
1550
(962)
|
| Title | Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma |
|---|---|
| Description | The PK parameter of maximum concentration (Cmax) was observed values. |
| Time Frame | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg |
|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 11 | 10 | 3 |
| Mean (Standard Deviation) [ng/mL] |
17.2
(6.25)
|
29.7
(7.50)
|
60.6
(11.8)
|
141
(61.7)
|
| Title | Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma |
|---|---|
| Description | The PK parameter of time to maximum concentration (Tmax) was observed values. When there are more than one time point, the time point when the concentration reached the first Cmax will be used as Tmax. |
| Time Frame | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg |
|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 11 | 10 | 3 |
| Mean (Standard Deviation) [hours] |
2.21
(2.18)
|
4.67
(2.29)
|
5.11
(1.85)
|
5.96
(0.03)
|
| Title | Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma |
|---|---|
| Description | The PK parameter of terminal half-life (T1/2) was calculated from the following formula in participants whose Kel could be calculated. T1/2=ln2 / Kel |
| Time Frame | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis set in participants with available sample for analysis. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg |
|---|---|---|---|---|
| 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. |
| Measure Participants | 1 | 3 | 5 | 3 |
| Mean (Standard Deviation) [hours] |
4.61
|
16.8
(1.74)
|
19.5
(10.5)
|
29.7
(2.35)
|
| Title | Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants |
|---|---|
| Description | The pharmacokinetic parameter of amount of drug excreted in urine was calculated from the following formula: urine concentration (ng/mL) /10^6× (urine weight / urinary specific gravity) |
| Time Frame | From start of treatment up to 24 hours post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set in participants with available sample for analysis. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg |
|---|---|---|---|---|
| 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. |
| Measure Participants | 6 | 9 | 10 | 3 |
| Mean (Standard Deviation) [mg] |
0.420
(0.0308)
|
0.880
(0.0683)
|
1.49
(0.309)
|
3.45
(0.417)
|
| Title | Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants |
|---|---|
| Description | The mean thrombin activatable fibrinolysis (TAFI) antigen levels and change from baseline in TAFI levels are reported. Change from baseline is based on the number of participants with baseline and at least one post-baseline laboratory test. |
| Time Frame | Baseline, 6 hours and 24 hours post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamic parameters were assessed in the Pharmacodynamic Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo |
|---|---|---|---|---|---|
| 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 placebo. |
| Measure Participants | 6 | 11 | 10 | 3 | 8 |
| Baseline |
99.17
(25.527)
|
80.05
(9.101)
|
79.56
(19.553)
|
81.90
(2.750)
|
88.28
(17.157)
|
| 6 hours postdose |
94.05
(22.090)
|
81.37
(11.358)
|
86.12
(13.727)
|
81.23
(6.313)
|
87.55
(15.987)
|
| 24 hours postdose |
87.75
(20.938)
|
78.09
(11.033)
|
77.62
(14.208)
|
72.70
(8.681)
|
79.11
(13.051)
|
| Change from baseline to 6 hour postdose |
-5.12
(6.463)
|
1.69
(5.077)
|
1.28
(8.551)
|
-0.67
(4.202)
|
-0.73
(5.579)
|
| Change from baseline to 24 hours postdose |
-11.42
(6.934)
|
-1.95
(9.641)
|
-5.09
(6.625)
|
-9.20
(6.070)
|
-9.16
(9.759)
|
| Title | Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants |
|---|---|
| Description | Mean D-dimer levels and change from baseline in D-dimer levels are reported.Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test. |
| Time Frame | Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamic parameters were assessed in the Pharmacodynamic Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo |
|---|---|---|---|---|---|
| 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 placebo. |
| Measure Participants | 6 | 11 | 10 | 3 | 8 |
| Baseline |
1.600
(2.8865)
|
0.730
(0.4176)
|
2.423
(4.8964)
|
0.613
(0.1250)
|
3.096
(6.8343)
|
| 6 hours postdose |
1.368
(2.1428)
|
0.717
(0.4899)
|
3.254
(6.3573)
|
1.090
(0.4540)
|
3.436
(7.3095)
|
| 24 hours postdose |
1.158
(1.6216)
|
0.960
(0.7254)
|
2.879
(6.0571)
|
1.067
(0.5235)
|
3.731
(7.1964)
|
| 48 hours postdose |
0.907
(1.1908)
|
0.912
(0.5107)
|
2.668
(6.0954)
|
1.287
(0.7371)
|
0.941
(0.5545)
|
| Change from baseline to 6 hour postdose |
-0.452
(1.0327)
|
-0.008
(0.1091)
|
1.497
(2.6031)
|
0.477
(0.5742)
|
-0.023
(0.1340)
|
| Change from baseline to 24 hours postdose |
-0.442
(1.2701)
|
0.217
(0.5241)
|
1.180
(2.4023)
|
0.453
(0.6422)
|
0.284
(0.4342)
|
| Change from baseline to 48 hours postdose |
-0.693
(1.6989)
|
0.163
(0.2431)
|
1.033
(2.4047)
|
0.673
(0.8559)
|
0.260
(0.4700)
|
| Title | Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants |
|---|---|
| Description | Mean activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) and change from baseline in TAFIa are reported. Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test. |
| Time Frame | Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamic parameters were assessed in the Pharmacodynamic Analysis Set. |
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo |
|---|---|---|---|---|---|
| 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 placebo. |
| Measure Participants | 6 | 11 | 10 | 3 | 8 |
| Baseline |
104.5
(30.68)
|
81.8
(17.67)
|
93.9
(28.92)
|
99.0
(8.54)
|
88.7
(18.99)
|
| 6 hours postdose |
110.4
(28.10)
|
77.9
(18.52)
|
82.7
(16.49)
|
68.7
(10.97)
|
95.5
(21.63)
|
| 24 hours postdose |
93.4
(29.03)
|
78.7
(14.58)
|
90.7
(18.67)
|
91.7
(7.51)
|
88.0
(16.00)
|
| 48 hours postdose |
91.2
(27.01)
|
70.0
(7.09)
|
84.7
(17.50)
|
88.7
(6.66)
|
87.6
(13.96)
|
| Change from baseline to 6 hours postdose |
-1.4
(11.04)
|
-2.6
(11.82)
|
-14.6
(16.00)
|
-30.3
(13.01)
|
8.0
(13.24)
|
| Change from baseline to 24 hours postdose |
-6.2
(7.56)
|
-5.5
(15.17)
|
-6.4
(12.03)
|
-7.3
(16.04)
|
0.6
(8.00)
|
| Change from baseline to 48 hours postdose |
-13.3
(9.99)
|
-6.9
(11.46)
|
-11.0
(10.92)
|
-10.3
(13.61)
|
-1.1
(13.95)
|
Adverse Events
| Time Frame | Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | A TEAE is defined as an adverse event (AE) that is not present prior to the study and occurs after the start of study drug administration but before Day 30, or an AE that worsens in severity after the start of study drug administration but before Day 30. | |||||||||
| Arm/Group Title | DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo | |||||
| 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 placebo. | |||||
All Cause Mortality |
||||||||||
| DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 2/9 (22.2%) | |||||
Serious Adverse Events |
||||||||||
| DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 2/12 (16.7%) | 2/11 (18.2%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Cardiac disorders | ||||||||||
| Acute myocardial infarction | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Infections and infestations | ||||||||||
| Sepsis | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Nervous system disorders | ||||||||||
| Brain oedema | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pneumonia aspiration | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Vascular disorders | ||||||||||
| Arterial occlusive disease | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| DS-1040b 0.6 mg | DS-1040b 1.2 mg | DS-1040b 2.4 mg | DS-1040b 4.8 mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/6 (83.3%) | 10/12 (83.3%) | 10/11 (90.9%) | 2/3 (66.7%) | 8/9 (88.9%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Cardiac disorders | ||||||||||
| Cardiac failure | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Eye disorders | ||||||||||
| Eye discharge | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 1/3 (33.3%) | 0/9 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Constipation | 2/6 (33.3%) | 2/12 (16.7%) | 3/11 (27.3%) | 1/3 (33.3%) | 3/9 (33.3%) | |||||
| Gingival bleeding | 0/6 (0%) | 1/12 (8.3%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Vomiting | 2/6 (33.3%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Diarrhoea | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Haematochezia | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Nausea | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Abdominal pain | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Acetonaemic vomiting | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Haemorrhoidal haemorrhage | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Lip haemorrhage | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Mouth haemorrhage | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Proctitis | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| General disorders | ||||||||||
| Pyrexia | 1/6 (16.7%) | 0/12 (0%) | 2/11 (18.2%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Vessel puncture site haematoma | 1/6 (16.7%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Puncture site haemorrhage | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Vessel puncture site haemorrhage | 1/6 (16.7%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatic function abnormal | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Liver disorder | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Infections and infestations | ||||||||||
| Urinary tract infection | 0/6 (0%) | 1/12 (8.3%) | 1/11 (9.1%) | 0/3 (0%) | 2/9 (22.2%) | |||||
| Respiratory tract infection | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 2/9 (22.2%) | |||||
| Periodontis | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Respiratory moniliasis | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Subcutaneous haematoma | 0/6 (0%) | 1/12 (8.3%) | 1/11 (9.1%) | 1/3 (33.3%) | 2/9 (22.2%) | |||||
| Pharyngeal injury | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Procedural haemorrhage | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Urethral injury | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Urinary tract injury | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Wound haemorrhage | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Investigations | ||||||||||
| Blood alkaline phosphatase increased | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Blood glucose increased | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Blood lactate dehydrogenase increased | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Blood phosphorus decreased | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Blood potassium decreased | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Blood pressure increased | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| C-reactive protein increased | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| ECG signs of myocardial ischaemia | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Haemoglobin decreased | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Liver function test increased | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Platelet count decreased | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hypokalaemia | 0/6 (0%) | 2/12 (16.7%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Dehydration | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Hypoalbuminaemia | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Hypocalcaemia | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Hypoglycaemia | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Hyponatraemia | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back pain | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Pain in extremity | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Metastases to lymph nodes | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Metastases to peritoneum | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Tumour associated fever | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Nervous system disorders | ||||||||||
| Subarachnoid haemorrhage | 1/6 (16.7%) | 1/12 (8.3%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Haemorrhagic cerebral infarction | 0/6 (0%) | 1/12 (8.3%) | 1/11 (9.1%) | 1/3 (33.3%) | 0/9 (0%) | |||||
| Cerebral infarction | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Carotid artery occlusion | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Cerebral artery embolism | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Cervicobrachial syndrome | 1/6 (16.7%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Dizziness | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Headache | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Loss of consciousness | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Neurological symptom | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Parkinsonism | 1/6 (16.7%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Syncope | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 0/6 (0%) | 0/12 (0%) | 2/11 (18.2%) | 1/3 (33.3%) | 0/9 (0%) | |||||
| Delirium | 0/6 (0%) | 2/12 (16.7%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Haemorrhage urinary tract | 0/6 (0%) | 1/12 (8.3%) | 2/11 (18.2%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Haematuria | 1/6 (16.7%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Neurogenic bladder | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Renal disorder | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pneumonia aspiration | 1/6 (16.7%) | 2/12 (16.7%) | 1/11 (9.1%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Apnoea | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Dyspnoea | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 1/3 (33.3%) | 0/9 (0%) | |||||
| Haemoptysis | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Pharyngeal haemorrhage | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Pleural effusion | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Respiratory tract haemorrhage | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermatitis diaper | 1/6 (16.7%) | 2/12 (16.7%) | 0/11 (0%) | 0/3 (0%) | 2/9 (22.2%) | |||||
| Skin exfoliation | 1/6 (16.7%) | 3/12 (25%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Dermatitis | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Pruritus | 0/6 (0%) | 1/12 (8.3%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Purpura | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
| Rash | 1/6 (16.7%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 0/9 (0%) | |||||
| Vascular disorders | ||||||||||
| Haemorrhagic infarction | 1/6 (16.7%) | 5/12 (41.7%) | 2/11 (18.2%) | 0/3 (0%) | 0/9 (0%) | |||||
| Haemorrhage | 0/6 (0%) | 0/12 (0%) | 2/11 (18.2%) | 0/3 (0%) | 0/9 (0%) | |||||
| Deep vein thrombosis | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Internal haemorrhage | 0/6 (0%) | 0/12 (0%) | 0/11 (0%) | 0/3 (0%) | 1/9 (11.1%) | |||||
| Venous thrombosis limb | 0/6 (0%) | 0/12 (0%) | 1/11 (9.1%) | 0/3 (0%) | 0/9 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | Contact for Clinical Trial Information |
|---|---|
| Organization | Daiichi Sankyo |
| Phone | 908-992-6400 |
| CTRinfo@dsi.com |
Responsible Party:
Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03198715
Other Study ID Numbers:
- DS1040-A-J110
- 173612
First Posted:
Jun 26, 2017
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021