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| ID | Type | Description | Link |
|---|---|---|---|
| 173612 | Registry Identifier | JAPIC CTI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-1040b 0.6 mg | Experimental | Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours |
|
| DS-1040b 1.2 mg | Experimental | Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours |
|
| DS-1040b 2.4 mg | Experimental | Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours |
|
| DS-1040b 4.8 mg | Experimental | Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours |
|
| Placebo | Placebo Comparator | Participants receive saline by intravenous infusion over six hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS1040b | Drug | DS-1040b in solution for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From start of treatment up to 36 hours post single, intravenous dose |
| Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants | Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin. | From start of treatment up to 96 hours post single, intravenous dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma | 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. | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirosaki University Hospital | Hirosaki | Aomori | 036-8563 | Japan | ||
| Funabashi Municipal Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35061236 | Derived | Sakai N, Takeuchi M, Imamura H, Shimamura N, Yoshimura S, Naito H, Kimura N, Masuo O, Hirotsune N, Morita K, Toyoda K, Yamagami H, Ishihara H, Nakatsu T, Miyoshi N, Suda M, Fujimoto S. Safety, Pharmacokinetics and Pharmacodynamics of DS-1040, in Combination with Thrombectomy, in Japanese Patients with Acute Ischemic Stroke. Clin Drug Investig. 2022 Feb;42(2):137-149. doi: 10.1007/s40261-021-01112-8. Epub 2022 Jan 21. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | DS-1040b 0.6 mg | Participants who received a single, intravenous infusion of DS-1040b 0.6 mg. |
| FG001 | DS-1040b 1.2 mg | Participants who received a single, intravenous infusion of DS-1040b 1.2 mg. |
| FG002 | DS-1040b 2.4 mg | Participants who received a single, intravenous infusion of DS-1040b 2.4 mg. |
| FG003 | DS-1040b 4.8 mg | Participants who received a single, intravenous infusion of DS-1040b 4.8 mg. |
| FG004 | Placebo | Participants who received a single, intravenous infusion of placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics and baseline characteristics were assessed in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | DS-1040b 0.6 mg | Participants who received a single, intravenous infusion of DS-1040b 0.6 mg. |
| BG001 | DS-1040b 1.2 mg | Participants who received a single, intravenous infusion of DS-1040b 1.2 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Bleeding events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | From start of treatment up to 36 hours post single, intravenous dose |
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DS-1040b 0.6 mg | Participants who received a single, intravenous infusion of DS-1040b 0.6 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2019 | Jan 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Placebo | Drug | Saline solution for intravenous infusion |
|
|
| Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma | The PK parameter of maximum concentration (Cmax) was observed values. | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
| Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma | 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. | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
| Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma | 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 | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
| Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants | 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) | From start of treatment up to 24 hours post single, intravenous dose |
| Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants | 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. | Baseline, 6 hours and 24 hours post single, intravenous dose |
| Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants | 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. | Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose |
| Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants | 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. | Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose |
| Funabashi |
| Chiba |
| 273-8588 |
| Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuota | 802-8555 | Japan |
| Mihara Memorial Hospital | Isesaki | Gunma | 372-0006 | Japan |
| Nakamura Memorial Hospital | Sapporo | Hokkaido | 060-8570 | Japan |
| Japan Organization of Occupational Health and Safety Kansai Rosai Hospital | Amagasaki | Hyōgo | 660-8511 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0046 | Japan |
| Hyogo College of Medicine College Hospital | Nishinomiya | Hyōgo | 663-8501 | Japan |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Iwate Prefectural Central Hospital | Morioka | Iwate | 020-0066 | Japan |
| Seisho Hospital | Odawara | Kanagawa | 250-0001 | Japan |
| Yokohama Municipal Citizen's Hospital | Yokohama | Kanagawa | 240-8555 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| National Cerebral and Cardiovascular Center | Suita | Osaka | 565-8565 | Japan |
| Saitama Medical University International Medical Center | Hidaka | Saitama | 350-1298 | Japan |
| Yamaguchi University Hospital | Ube | Yamaguchi | 755-8505 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8521 | Japan |
| Niigata City General Hospital | Niigata | 950-1197 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8509 | Japan |
| Other |
|
| BG002 | DS-1040b 2.4 mg | Participants who received a single, intravenous infusion of DS-1040b 2.4 mg. |
| BG003 | DS-1040b 4.8 mg | Participants who received a single, intravenous infusion of DS-1040b 4.8 mg. |
| BG004 | Placebo | Participants who received a single, intravenous infusion of placebo. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | DS-1040b 0.6 mg | Participants who received a single, intravenous infusion of DS-1040b 0.6 mg. |
| OG001 | DS-1040b 1.2 mg | Participants who received a single, intravenous infusion of DS-1040b 1.2 mg. |
| OG002 | DS-1040b 2.4 mg | Participants who received a single, intravenous infusion of DS-1040b 2.4 mg. |
| OG003 | DS-1040b 4.8 mg | Participants who received a single, intravenous infusion of DS-1040b 4.8 mg. |
| OG004 | Placebo | Participants who received a single, intravenous infusion of placebo. |
|
|
| Primary | Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants | Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin. | Bleeding events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | From start of treatment up to 96 hours post single, intravenous dose |
|
|
|
| Secondary | Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma | 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 parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng*h/mL | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
|
|
|
| Secondary | Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma | The PK parameter of maximum concentration (Cmax) was observed values. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
|
|
|
| Secondary | Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma | 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 parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | hours | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
|
|
|
| Secondary | Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma | 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 parameters were assessed in the Pharmacokinetic Analysis set in participants with available sample for analysis. | Posted | Mean | Standard Deviation | hours | Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose |
|
|
|
| Secondary | Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set in participants with available sample for analysis. | Posted | Mean | Standard Deviation | mg | From start of treatment up to 24 hours post single, intravenous dose |
|
|
|
| Secondary | Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants | 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 parameters were assessed in the Pharmacodynamic Analysis Set. | Posted | Mean | Standard Deviation | % of normal pooled plasma control | Baseline, 6 hours and 24 hours post single, intravenous dose |
|
|
|
| Secondary | Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants | 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 parameters were assessed in the Pharmacodynamic Analysis Set. | Posted | Mean | Standard Deviation | ug/mL FEU | Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose |
|
|
|
| Secondary | Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants | 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. | Pharmacodynamic parameters were assessed in the Pharmacodynamic Analysis Set. | Posted | Mean | Standard Deviation | % of normal pooled plasma control | Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | DS-1040b 1.2 mg | Participants who received a single, intravenous infusion of DS-1040b 1.2 mg. | 0 | 12 | 2 | 12 | 10 | 12 |
| EG002 | DS-1040b 2.4 mg | Participants who received a single, intravenous infusion of DS-1040b 2.4 mg. | 1 | 11 | 2 | 11 | 10 | 11 |
| EG003 | DS-1040b 4.8 mg | Participants who received a single, intravenous infusion of DS-1040b 4.8 mg. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG004 | Placebo | Participants who received a single, intravenous infusion of placebo. | 2 | 9 | 1 | 9 | 8 | 9 |
| Brain oedema | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Periodontis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory moniliasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemorrhagic infarction | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Internal haemorrhage | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acetonaemic vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lip haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Puncture site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| ECG signs of myocardial ischaemia | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Pharyngeal injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Urethral injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|
| 6 hours postdose |
|
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| 24 hours postdose |
|
|
| Change from baseline to 6 hour postdose |
|
|
| Change from baseline to 24 hours postdose |
|
|
|
| 6 hours postdose |
|
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| 24 hours postdose |
|
|
| 48 hours postdose |
|
|
| Change from baseline to 6 hour postdose |
|
|
| Change from baseline to 24 hours postdose |
|
|
| Change from baseline to 48 hours postdose |
|
|
|
| 6 hours postdose |
|
|
| 24 hours postdose |
|
|
| 48 hours postdose |
|
|
| Change from baseline to 6 hours postdose |
|
|
| Change from baseline to 24 hours postdose |
|
|
| Change from baseline to 48 hours postdose |
|
|