Trial Outcomes & Findings for Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (NCT NCT03860935)

Last Updated: 2024-06-27

Results Overview

The endpoint was analyzed using Finkelstein-Schoenfeld method. The method combines all-cause mortality, cumulative frequency of CV-related hospitalizations, change from baseline in NT-proBNP and change from baseline in 6MWT in a hierarchical fashion. The method compares every participant with every other participant within strata, assigning a +1 to the "better" participant and a -1 to the "worse" participant and 0 if they are "tied". Participants who had heart transplantation or implantation of a cardiac mechanical assist device were handled in the same manner as death. 'Win' represents a participant doing better based on hierarchical comparison. The reported unit is the total percent of "wins" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

632 participants

Primary outcome timeframe

Baseline up to Month 30

Results posted on

2024-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Acoramidis HCl 800 mg Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
Overall Study STARTED	421	211
Overall Study COMPLETED	331	154
Overall Study NOT COMPLETED	90	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Acoramidis HCl 800 mg Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
Overall Study Withdrawal of Consent	15	6
Overall Study Death	75	51

Baseline Characteristics

Participants evaluable by each baseline assessment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acoramidis HCl 800 mg n=421 Participants Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=211 Participants Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)	Total n=632 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=421 Participants	0 Participants n=211 Participants	0 Participants n=632 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=421 Participants	9 Participants n=211 Participants	21 Participants n=632 Participants
Age, Categorical >=65 years	409 Participants n=421 Participants	202 Participants n=211 Participants	611 Participants n=632 Participants
Age, Continuous	77.37 years STANDARD_DEVIATION 6.450 • n=421 Participants	77.09 years STANDARD_DEVIATION 6.763 • n=211 Participants	77.27 years STANDARD_DEVIATION 6.552 • n=632 Participants
Sex: Female, Male Female	37 Participants n=421 Participants	25 Participants n=211 Participants	62 Participants n=632 Participants
Sex: Female, Male Male	384 Participants n=421 Participants	186 Participants n=211 Participants	570 Participants n=632 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=421 Participants	4 Participants n=211 Participants	12 Participants n=632 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	401 Participants n=421 Participants	199 Participants n=211 Participants	600 Participants n=632 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=421 Participants	8 Participants n=211 Participants	20 Participants n=632 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=421 Participants	1 Participants n=211 Participants	1 Participants n=632 Participants
Race (NIH/OMB) Asian	10 Participants n=421 Participants	3 Participants n=211 Participants	13 Participants n=632 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=421 Participants	1 Participants n=211 Participants	1 Participants n=632 Participants
Race (NIH/OMB) Black or African American	20 Participants n=421 Participants	10 Participants n=211 Participants	30 Participants n=632 Participants
Race (NIH/OMB) White	368 Participants n=421 Participants	187 Participants n=211 Participants	555 Participants n=632 Participants
Race (NIH/OMB) More than one race	2 Participants n=421 Participants	0 Participants n=211 Participants	2 Participants n=632 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=421 Participants	9 Participants n=211 Participants	30 Participants n=632 Participants
Distance Walked During the 6 Minute Walk Test (6MWT)	361.21 Meter STANDARD_DEVIATION 103.705 • n=419 Participants • Participants evaluable by each baseline assessment.	348.37 Meter STANDARD_DEVIATION 93.564 • n=211 Participants • Participants evaluable by each baseline assessment.	356.91 Meter STANDARD_DEVIATION 100.531 • n=630 Participants • Participants evaluable by each baseline assessment.
Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)	71.52 units on a scale STANDARD_DEVIATION 19.387 • n=420 Participants • Participants evaluable by each baseline assessment	70.31 units on a scale STANDARD_DEVIATION 20.541 • n=211 Participants • Participants evaluable by each baseline assessment	71.12 units on a scale STANDARD_DEVIATION 19.773 • n=631 Participants • Participants evaluable by each baseline assessment
Serum TTR (Prealbumin) Level	23.16 mg/dL STANDARD_DEVIATION 5.643 • n=418 Participants • Participants evaluable by each baseline assessment	23.63 mg/dL STANDARD_DEVIATION 6.070 • n=208 Participants • Participants evaluable by each baseline assessment	23.32 mg/dL STANDARD_DEVIATION 5.788 • n=626 Participants • Participants evaluable by each baseline assessment

PRIMARY outcome

Timeframe: Baseline up to Month 30

Population: The mITT population includes subjects who meet the definition of ITT which includes all randomized subjects who received at least one dose of IMP and have at least one post baseline efficacy assessment as well as an additional requirement which is to have a baseline eGFR \>= 30 mL/min/1.73 m\^2 . Subjects in this population were analyzed according to their assigned randomized treatment.

Outcome measures

Outcome measures
Measure	Acoramidis HCl 800 mg n=409 Participants Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=202 Participants Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
A Hierarchical Combination of All-Cause Mortality, Cumulative Frequency of CV-related Hospitalization, Change From Baseline in NT-proBNP and Change From Baseline in 6MWT at the Last Available Visit Where Both Subjects Had Non-missing Assessments.	63.7 Percent of Wins from Win Ratio	35.9 Percent of Wins from Win Ratio

SECONDARY outcome

Timeframe: Month 30

6MWT measures the total distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.

Outcome measures

Outcome measures
Measure	Acoramidis HCl 800 mg n=384 Participants Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=186 Participants Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
Change From Baseline to Month 30 in the Distance Walked During the 6 Minute Walk Test (6MWT)	-64.65 Meter Standard Error 5.508	-104.29 Meter Standard Error 7.772

SECONDARY outcome

Timeframe: Month 30

KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). The summary score of Overall Summary (calculated as mean of Physical limitation, Social limitation, Total symptoms, and Quality of life scores) was calculated. Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status.

Outcome measures

Outcome measures
Measure	Acoramidis HCl 800 mg n=405 Participants Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=201 Participants Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
Change From Baseline to Month 30 of the Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)	-11.48 Score on a scale Standard Error 1.181	-21.42 Score on a scale Standard Error 1.651

SECONDARY outcome

Timeframe: Month 30

Serum TTR (Prealbumin) is an in vivo biomarker of stabilization.

Outcome measures

Outcome measures
Measure	Acoramidis HCl 800 mg n=397 Participants Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=197 Participants Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
Change From Baseline to Month 30 in Serum TTR (Prealbumin) Level	5.78 mg/dL Standard Error 0.391	-1.32 mg/dL Standard Error 0.541

SECONDARY outcome

Timeframe: Baseline up to Month 30

Number of deaths due to any cause was analyzed. Participants who had heart transplantation or implantation of a CMAD were handled in the same manner as death.

Outcome measures

Outcome measures
Measure	Acoramidis HCl 800 mg n=409 Participants Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=202 Participants Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
All-cause Mortality by Month 30, Including Death Due to Any Cause, Heart Transplant or Cardiac Mechanical Assist Device (CMAD)	79 Participants	52 Participants

Adverse Events

Acoramidis HCl 800 mg

Serious events: 230 serious events

Other events: 410 other events

Deaths: 84 deaths

Placebo

Serious events: 137 serious events

Other events: 199 other events

Deaths: 55 deaths

Serious adverse events

Other adverse events

Additional Information

VP, Clinical Operations

Eidos Therapeutics, Inc., a BridgeBio Company

Phone: 415-887-1471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Acoramidis HCl 800 mg n=421 participants at risk Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=211 participants at risk Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
Cardiac disorders Cardiac failure	10.7% 45/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	18.5% 39/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac failure acute	5.0% 21/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	6.6% 14/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Atrial fibrillation	4.5% 19/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	7.1% 15/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Bradycardia	2.6% 11/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.95% 2/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Ventricular tachycardia	1.4% 6/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	2.4% 5/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Atrioventricular block complete	1.9% 8/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.4% 3/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Acute myocardial infarction	1.2% 5/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.9% 4/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac failure chronic	1.4% 6/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.4% 3/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac arrest	0.95% 4/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.9% 4/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac failure congestive	1.2% 5/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.4% 3/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiorenal syndrome	0.71% 3/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.4% 3/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Atrial flutter	0.71% 3/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.4% 3/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Acute left ventricular failure	0.71% 3/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.95% 2/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiogenic shock	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.4% 3/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Atrioventricular block	0.48% 2/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.95% 2/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac amyloidosis	0.48% 2/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.95% 2/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Angina pectoris	0.48% 2/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Right ventricular failure	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.95% 2/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Sinus node dysfunction	0.71% 3/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Trifascicular block	0.48% 2/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Atrial tachycardia	0.48% 2/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Chronic left ventricular failure	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Aortic valve stenosis	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Atrial thrombosis	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Bifascicular block	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Bradyarrhythmia	0.00% 0/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Bundle branch block	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac flutter	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac tamponade	0.00% 0/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Coronary artery disease	0.00% 0/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Mitral valve incompetence	0.00% 0/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Myocardial infarction	0.00% 0/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Myocardial ischaemia	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Palpitations	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Pericarditis	0.00% 0/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.47% 1/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Supraventricular tachycardia	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Ventricular fibrillation	0.24% 1/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	0.00% 0/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Infections and infestations Pneumonia	2.9% 12/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	2.8% 6/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Infections and infestations COVID-19	2.1% 9/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.9% 4/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.

Other adverse events
Measure	Acoramidis HCl 800 mg n=421 participants at risk Participants with symptomatic ATTR-CM received 800 mg acoramidis HCl BID (two 400 mg acoramidis HCl tablets, each equivalent to 356 mg acoramidis \[active moiety\])	Placebo n=211 participants at risk Participants with symptomatic ATTR-CM received matching placebo (two matching placebo tablets BID)
Infections and infestations COVID-19	19.0% 80/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	12.8% 27/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Infections and infestations Urinary tract infection	10.9% 46/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	12.3% 26/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Infections and infestations Upper respiratory tract infection	5.2% 22/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.7% 12/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Infections and infestations Nasopharyngitis	5.0% 21/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.2% 11/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Gastrointestinal disorders Constipation	12.1% 51/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	14.7% 31/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Gastrointestinal disorders Diarrhoea	11.4% 48/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	7.6% 16/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Gastrointestinal disorders Nausea	5.7% 24/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.2% 11/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Gastrointestinal disorders Abdominal pain upper	5.2% 22/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.4% 3/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Cardiac failure	16.4% 69/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	28.9% 61/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Atrial fibrillation	13.1% 55/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	17.1% 36/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Cardiac disorders Ventricular tachycardia	2.9% 12/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.7% 12/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Musculoskeletal and connective tissue disorders Arthralgia	11.2% 47/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	10.4% 22/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Musculoskeletal and connective tissue disorders Back pain	9.0% 38/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	6.6% 14/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Musculoskeletal and connective tissue disorders Muscle spasms	8.1% 34/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	7.1% 15/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 30/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.2% 11/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Nervous system disorders Dizziness	10.7% 45/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	10.4% 22/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Nervous system disorders Syncope	3.6% 15/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.7% 12/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Metabolism and nutrition disorders Gout	10.9% 46/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	8.1% 17/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Metabolism and nutrition disorders Hypervolaemia	5.0% 21/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	8.1% 17/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Metabolism and nutrition disorders Hypokalaemia	5.0% 21/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.2% 11/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Metabolism and nutrition disorders Decreased appetite	4.5% 19/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.2% 11/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.1% 51/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	17.5% 37/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Respiratory, thoracic and mediastinal disorders Cough	7.6% 32/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	8.5% 18/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 21/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	3.3% 7/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
General disorders Fatigue	10.0% 42/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	12.3% 26/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
General disorders Oedema peripheral	7.8% 33/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	11.8% 25/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
General disorders Asthenia	5.0% 21/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	3.8% 8/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
General disorders Peripheral swelling	1.4% 6/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	6.6% 14/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Injury, poisoning and procedural complications Fall	14.0% 59/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	18.0% 38/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Injury, poisoning and procedural complications Skin laceration	2.6% 11/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.2% 11/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Investigations Blood creatinine increased	6.2% 26/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	1.9% 4/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Investigations Weight decreased	3.8% 16/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	6.2% 13/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Renal and urinary disorders Renal impairment	8.3% 35/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	8.1% 17/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Renal and urinary disorders Acute kidney injury	8.3% 35/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	7.6% 16/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Renal and urinary disorders Haematuria	4.0% 17/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	7.6% 16/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Skin and subcutaneous tissue disorders Pruritus	5.9% 25/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	3.8% 8/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Skin and subcutaneous tissue disorders Rash	5.0% 21/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	5.2% 11/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Vascular disorders Hypotension	7.1% 30/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	6.6% 14/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Psychiatric disorders Insomnia	4.8% 20/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	7.1% 15/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.
Blood and lymphatic system disorders Anaemia	7.8% 33/421 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.	7.1% 15/211 • In Study AG10-301 participants, treatment emergent adverse events (TEAEs) are defined as (a) events with onset after the first dose of study drug, or (b) if the event was present before the first dose of study drug, but increased in severity after the first dose of study drug, and (c) with onset date or severity increase date <= 30 days after the last dose of study drug (through AG10-301 Study completion, 30 months) or until the first dose in open label extension Study AG10-304. Study AG10-301 TEAEs are any untoward or unfavorable medical occurrence in a participant, whether or not considered related to the participant's participation in the research, with event onset date or increase in severity date as defined in the Time Frame Section above. Serious TEAEs and non-serious TEAEs are also presented separately below.