Exploratory Study of Danicamtiv in Patients With Primary... | NCT04572893

ID	Type	Description	Link
2019-003626-24	EudraCT Number

Label	Type	Description	Intervention Names
MYK-491	Experimental	Primary DCM due to MYH7 or TTN Variant or due to other causalities not related to MYH7 or TTN variants	Drug: danicamtiv

Name	Type	Description	Arm Group Labels	Other Names
danicamtiv	Drug	Myosin activator	MYK-491	MYK-491 BMS-986434

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) in Part A	An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.	From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Serious Adverse Events (SAEs) in Part A	An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event.	From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Safety Laboratory Assessments by Intensity in Part A	Number of participants with safety laboratory assessments by intensity. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities.	From first dose to 14 days post last dose (Up to approximately 13 weeks)
Number of Participants With Clinically Significant Changes in Physical Examinations in Part A	Number of participants with clinically significant changes in physical examinations.	From first dose to 30 days post last dose (Up to approximately 15 weeks)
Number of Participants With Clinically Significant Changes in Vital Signs in Part A	Number of participants with clinically significant changes in vital signs.

Secondary Outcomes

Measure	Description	Time Frame
Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline	Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days.	Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0007		La Jolla	California	92037	United States
Local Institution - 0010

PubMed Identifier	Type	Citation	Retractions
41217321	Derived	Lakdawala NK, Hershberger RE, Garcia-Pavia P, Elliott PM, Ginns J, Meder B, Solomon S, Cunningham JW, Gimeno JR, Barriales-Villa R, Adler E, Gerull B, Pereira NL, Halliday BP, Li W, Jarugula P, Maruyama S, Mohran SE, Papadaki M, Anto AR, Anderson RL, Rodriguez HM, Del Rio CL, Edelberg JM, Kurio G, Maya J, Januzzi JL. Danicamtiv, a Selective Agonist of Cardiac Myosin, for Dilated Cardiomyopathy: A Phase 2 Open-Label Trial. J Am Coll Cardiol. 2025 Dec 23;86(25):2598-2612. doi: 10.1016/j.jacc.2025.09.1511. Epub 2025 Sep 29.

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
FG001	Part A - TTN - MYK-491

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	Aug 28, 2023

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 Adverse Events (AEs) in Part A

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.

All treated participants in Part A as pre-specified in protocol.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to approximately 15 weeks)

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG003	Part A - DCM-Non Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Non genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Units	Counts
Participants	OG00012 OG00114 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009 OG0019 OG0024 OG003

Primary

Number of Participants With Serious Adverse Events (SAEs) in Part A

An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event.

All treated participants in Part A as pre-specified in protocol.

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to approximately 15 weeks)

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Primary

Number of Participants With Safety Laboratory Assessments by Intensity in Part A

Number of participants with safety laboratory assessments by intensity. Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities.

All treated participants in Part A as pre-specified in protocol

Posted

Count of Participants

Participants

From first dose to 14 days post last dose (Up to approximately 13 weeks)

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Ventricular Ejection Time (LVET) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

msec

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Primary

Number of Participants With Clinically Significant Changes in Physical Examinations in Part A

Number of participants with clinically significant changes in physical examinations.

All treated participants in Part A as pre-specified in protocol

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to approximately 15 weeks)

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG003	Part A - DCM-Non Genetic - MYK-491

Primary

Number of Participants With Clinically Significant Changes in Vital Signs in Part A

Number of participants with clinically significant changes in vital signs.

All treated participants in Part A as pre-specified in protocol

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to approximately 15 weeks)

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG003	Part A - DCM-Non Genetic - MYK-491

Primary

Number of Participants With Clinically Significant Changes in 12-Lead ECG Recordings in Part A

Number of participants with clinically significant changes in 12-lead ECG recordings.

All treated participants in Part A as pre-specified in protocol

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (Up to approximately 15 weeks)

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG003	Part A - DCM-Non Genetic - MYK-491

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Intensity in Part A

Mild=An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; Moderate= An event causing sufficient discomfort and interferes with normal everyday activities.

Severe= An event preventing normal everyday activities. (An AE that is assessed as severe should not be confused with a SAE. Severe is a category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.)

All treated participants in Part A as pre-specified in protocol

Posted

Count of Participants

Participants

From first dose to 14 days post last dose (Up to approximately 13 weeks)

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Ventricular Stroke Volume (LVSV) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Ventricular Ejection Fraction (LVEF) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

percentage

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Ventricular Global Longitudinal Strain (LVGLS) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

percentage

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Ventricular Global Circumferential Strain (LVGCS) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

percentage

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Lateral Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

cm/s

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) S Prime Septal Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

cm/s

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Diameter (LVESD) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Systolic Volumen Index (LVESVi) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

mL/m^2

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Diameter (LVEDD) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) Left Ventricular End-Diastolic Volumen Index (LVEDVi) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

m1/m2

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 42, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Lateral Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

cm/s

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Tissue Doppler Imaging (TDI) E Prime Septal Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

cm/s

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) E/E Prime Average Ratio Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

E/E prime ratio

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) E/E Prime Lateral Ratio Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

E/E prime ratio

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) E/E Prime Septal Ratio Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

E/E prime ratio

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Ratio of Peak Inflow Velocities in Early and Late Diastole - E/A Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

E/A ratio

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Atrial Minimum Volume (LAminV) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Atrial Maximum Volume Index (LAmaxVi) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

mL/m^2

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Atrial Emptying Fraction (LAEF) Change From Baseline

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

Percent change

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Secondary

Transthoracic Echo (TTE) Left Atrial Function Index (LAFI) Change From Baseline

Baseline is defined as the last non-missing result prior to the first dose of study medication. for part B, baseline is defined as visit 1B regardless of rescreening. Treatment periods 1 and 2 are 5 to 8 days. Higher LAFI values are considered better left atrial function while lower LFAI values may indicate left atrial dysfunction.

All treated participants with baseline and post baseline measurements at the specified timepoints

Posted

Mean

Standard Deviation

Index

Part A: Baseline, end of treatment period 1. end of treatment period 2, early termination; Part B: Baseline, weeks 2, 6, 12, 24, 36, 48, and early termination

ID	Title	Description
OG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
OG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A - MYH7 - MYK-491 25 mg BID	Participants with MYH7 variant received 25 mg BID Danicamtiv	12	0	12	5	12
EG001	Part A - TTN - MYK-491 25 mg BID	Participants with TTN variant received 25 mg BID Danicamtiv	14	0	14	3	14
EG002	Part A - DCM-Genetic - MYK-491 25 mg BID	Participants with DCM-Genetic variant received 25 mg BID Danicamtiv	5	0	5	1	5
EG003	Part A - DCM-Non Genetic - MYK-491 25 mg BID	Participants with DCM-Non genetic variant received 25 mg BID Danicamtiv	10	0	10	2	10
EG004	Part A - MYH7 - MYK-491 50 mg BID	Participants with MYH7 variant received 50 mg BID Danicamtiv	12	0	12	5	12
EG005	Part A - TTN - MYK-491 50 mg BID	Participants with TTN variant received 50 mg BID Danicamtiv	14	0	14	5	14
EG006	Part A - DCM-Genetic - MYK-491 50 mg BID	Participants with DCM-Genetic variant received 50 mg BID Danicamtiv	4	0	4	2	4
EG007	Part A - DCM-Non Genetic - MYK-491 50 mg BID	Participants with DCM-Non genetic variant received 50 mg BID Danicamtiv	9	0	9	2	9
EG008	Part A - DCM-Genetic - MYK-491 10 mg BID	Participants with DCM-Genetic variant received 10 mg BID Danicamtiv	1	0	1	0	1
EG009	Part A - DCM-Non Genetic - MYK-491 10 mg BID	Participants with DCM-Non genetic variant received 10 mg BID Danicamtiv	1	0	1	0	1
EG010	Part B - MYH7 - MYK-491 25 mg BID	Participants with MYH7 variant received 25 mg BID Danicamtiv	1	0	1	1	1
EG011	Part B - MYH7 - MYK-491 50 mg BID	Participants with MYH7 variant received 50 mg BID Danicamtiv	4	1	4	3	4
EG012	Part B - TTN - MYK-491 50 mg BID	Participants with TTN variant received 50 mg BID Danicamtiv	4	1	4	3	4
EG013	Part B - DCM-Non Genetic - MYK-491 50 mg BID	Participants with DCM-Non genetic variant received 50 mg BID Danicamtiv	1	0	1	0	1
EG014	Part B - MYH7 - MYK-491 75 mg BID	Participants with MYH7 variant received 75 mg BID Danicamtiv	5	0	5	5	5
EG015	Part B - TTN - MYK-491 75 mg BID	Participants with TTN variant received 75 mg BID Danicamtiv	4	2	4	4	4
EG016	Part B - DCM-Non Genetic - MYK-491 75 mg BID	Participants with DCM-Non genetic variant received 75 mg BID Danicamtiv	3	1	3	2	3

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial flutter	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG0030 affected10 at risk EG0040 affected12 at risk EG0050 affected14 at risk EG0060 affected4 at risk EG0070 affected9 at risk EG0080 affected1 at risk EG0090 affected1 at risk EG0100 affected1 at risk EG0111 affected4 at risk EG0120 affected4 at risk EG0130 affected1 at risk EG0140 affected5 at risk EG0150 affected4 at risk EG0160 affected3 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Palpitations	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Chalazion	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Application site rash	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Chills	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Cystitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Fibrin D dimer increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
International normalised ratio increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Liver function test increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Troponin I increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Device inappropriate shock delivery	Product Issues	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Initial insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hot flush	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003

ID	Term
D055036	Campomelic Dysplasia
D002311	Cardiomyopathy, Dilated
C536231	familial dilated cardiomyopathy
D049310	Distal Myopathies
D009477	Hereditary Sensory and Autonomic Neuropathies

ID	Term
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009202	Cardiomyopathies
D000083083	Laminopathies
D030342	Genetic Diseases, Inborn
D009136	Muscular Dystrophies
D020966	Muscular Disorders, Atrophic
D009135	Muscular Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009421	Nervous System Malformations
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D011115	Polyneuropathies
D010523	Peripheral Nervous System Diseases

ID	Title	Description
BG000	Part A - MYH7 - MYK-491	Participants with myosin heavy chain 7 (MYH7) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
BG001	Part A - TTN - MYK-491	Participants with titin (TTN) variant received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
BG002	Part A - DCM-Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
BG003	Part A - DCM-Non Genetic - MYK-491	Participants with dilated cardiomyopathy (DCM)-Non genetic received Danicamtiv. Study drug will be administered orally BID for at least 5 days and up to 8 days for each Treatment Period
BG004	Total	Total of all reporting groups

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmic storm	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG0030 affected10 at risk EG0040 affected12 at risk EG0050 affected14 at risk EG0060 affected4 at risk EG0070 affected9 at risk EG0080 affected1 at risk EG0090 affected1 at risk EG0100 affected1 at risk EG0110 affected4 at risk EG0120 affected4 at risk EG0130 affected1 at risk EG0140 affected5 at risk EG0151 affected4 at risk EG0160 affected3 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003