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| Name | Class |
|---|---|
| Merck Serono Co., Ltd., China | INDUSTRY |
This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment plus nicorandil | Experimental | The subjects will receive nicorandil 5 milligram (mg ) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (such as aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [(ACEIs] as permitted by disease condition /as per standard local practices/prescribed per discretion of investigators). |
|
| Standard treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorandil | Drug | The subjects will receive Nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with the standard treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Myocardial Ischemia Attacks in 24 Hours | Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (>=) 0.1 millivolts (mV), and lasted for >= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia. | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Myocardial Ischemic Burden at Week 12 | The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours. | Baseline, Week 12 |
| Change From Baseline in Maximum ST-depression at Week 12 |
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Inclusion Criteria:
Subject must be diagnosed as stable CHD, and must have at least one of these histories:
Subjects must have at least 2 times of typical symptoms of myocardial ischemia occurred within a week Other protocol defined inclusion criteria could apply
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For Locations in | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27657471 | Derived | Jiang J, Li Y, Zhou Y, Li X, Li H, Tang B, Dai X, Ma T, Li L, Huo Y. Oral nicorandil reduces ischemic attacks in patients with stable angina: A prospective, multicenter, open-label, randomized, controlled study. Int J Cardiol. 2016 Dec 1;224:183-187. doi: 10.1016/j.ijcard.2016.08.305. Epub 2016 Aug 21. |
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4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received. Thus, safety set have 197 and 205 in Standard+nicorandil and standard group, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment Plus Nicorandil | The subjects received nicorandil 5 milligram (mg) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors (ACEIs) as permitted by disease condition or as per standard local practices or prescribed per discretion of the investigators. |
| FG001 | Standard Treatment | The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) included all randomized subjects who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment Plus Nicorandil | The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Myocardial Ischemia Attacks in 24 Hours | Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (>=) 0.1 millivolts (mV), and lasted for >= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ischemic attacks per 24 hours | At Week 12 |
|
From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks ).
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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 | Standard Treatment Plus Nicorandil | The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020108 | Nicorandil |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
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| Standard Treatment | Drug | The subjects will receive one of the standard anti-anginal therapies which included but not limited to aspirin, ACEI, lipid lowering statins and beta blockers according to the recommendation of guidelines. If the subject's condition permitted, they should take all these medicines. However, the dose, route, frequency and duration were determined by investigators according to subject's specific condition. |
|
The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation. |
| Baseline, Week 12 |
| Change From Baseline in Longest Duration of ST Segment Depression at Week 12 | The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack. | Baseline, Week 12 |
| Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test | The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter. | At Week 12 |
| Heart Rate Variability (HRV) Rate: Time Domain | HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means. | At Week 12 |
| Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour | HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours. | At Week 12 |
| Number of Arrhythmia Occurred Within 24 Hours | The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours. | At Week 12 |
| ECG QT Dispersion | The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12-lead ECG. | At Week 12 |
| Number of Subjects Experienced Angina Attack | Baseline up to 12 Weeks |
| Frequency of Angina Attack | The total number of times angina attacks occurred within a week (number of times/week) | At Week 12 |
| Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin | At Week 12 |
| Number of Nitroglycerin Tablets Consumed in a Week | At Week 12 |
| Walk Distance in Six Minute Walk (6-MWT) Test at Week 12 | The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter. | At Week 12 |
| Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks ) |
| Number of Subjects Who Showed Compliance to Nicorandil | Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated. | Baseline up to 12 Weeks |
| Adverse Event |
|
| Lost to Follow-up |
|
| Other |
|
| BG001 | Standard Treatment | The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Standard Treatment | The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators. |
|
|
|
| Secondary | Change From Baseline in Total Myocardial Ischemic Burden at Week 12 | The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack. | Posted | Mean | Standard Deviation | millimeter*minutes | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Maximum ST-depression at Week 12 | The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack. | Posted | Mean | Standard Deviation | millimeter | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Longest Duration of ST Segment Depression at Week 12 | The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack. | Posted | Mean | Standard Deviation | seconds | Baseline, Week 12 |
|
|
|
| Secondary | Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test | The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack. | Posted | Number | percentage of subjects | At Week 12 |
|
|
|
| Secondary | Heart Rate Variability (HRV) Rate: Time Domain | HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means. | FAS included all randomized subjects who received at least one dose of study treatment. "n" signifies the number of subjects evaluable for each category in each group for this outcome measure, respectively. | Posted | Mean | Standard Deviation | millisecond | At Week 12 |
|
|
|
| Secondary | Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour | HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millisecond square (ms^2) | At Week 12 |
|
|
|
| Secondary | Number of Arrhythmia Occurred Within 24 Hours | The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per 24 hours | At Week 12 |
|
|
|
| Secondary | ECG QT Dispersion | The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12-lead ECG. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milliseconds | At Week 12 |
|
|
|
| Secondary | Number of Subjects Experienced Angina Attack | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Number | subjects | Baseline up to 12 Weeks |
|
|
|
| Secondary | Frequency of Angina Attack | The total number of times angina attacks occurred within a week (number of times/week) | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | angina attacks per week | At Week 12 |
|
|
|
| Secondary | Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Number | subjects | At Week 12 |
|
|
|
| Secondary | Number of Nitroglycerin Tablets Consumed in a Week | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | tablets per week | At Week 12 |
|
|
|
| Secondary | Walk Distance in Six Minute Walk (6-MWT) Test at Week 12 | The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter. | FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure. | Posted | Mean | Standard Deviation | meters | At Week 12 |
|
|
|
| Secondary | Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received. | Posted | Number | subjects | From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks ) |
|
|
|
| Secondary | Number of Subjects Who Showed Compliance to Nicorandil | Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated. | Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received. | Posted | Number | subjects | Baseline up to 12 Weeks |
|
|
|
| 9 |
| 197 |
| 12 |
| 197 |
| EG001 | Standard Treatment | The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators. | 7 | 205 | 1 | 205 |
| Cardiac sudden death | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Angina | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Unstable angina | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Peripheral edema | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Diabetes | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Gastroenteritis' | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Increased blood pressure | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Chronic renal failure | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
Not provided
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000147 |
| Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| SDNN index (n=140, 147) |
|
| AEs Leading to Death |
|
| AEs Leading to Discontinuation |
|