Trial Outcomes & Findings for Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease (NCT NCT03486938)

Last Updated: 2024-05-17

Results Overview

CDR-SB scores at baseline were subtracted from CDR-SB scores at week 78 to generate the change score from baseline, with a possible total range of -18 to 18. Positive change scores reflect greater impairment on the CDR-SB at week 78, while negative change scores reflect less impairment on the CDR-SB at week 78.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

164 participants

Primary outcome timeframe

78 weeks

Results posted on

2024-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Oral Tablet Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Placebo Oral Tablet: Placebo oral tablet	AGB101 220 mg Tablet Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. AGB101 220 mg tablet: 220 mg AGB101 active compound
Overall Study STARTED	83	81
Overall Study COMPLETED	66	55
Overall Study NOT COMPLETED	17	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline FAQ measure not collected for 7 subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Oral Tablet n=83 Participants Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Placebo Oral Tablet: Placebo oral tablet	AGB101 220 mg Tablet n=81 Participants Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. AGB101 220 mg tablet: 220 mg AGB101 active compound	Total n=164 Participants Total of all reporting groups
Age, Continuous	73.1 years STANDARD_DEVIATION 7 • n=83 Participants	72.2 years STANDARD_DEVIATION 6.7 • n=81 Participants	72.7 years STANDARD_DEVIATION 6.9 • n=164 Participants
Sex: Female, Male Female	40 Participants n=83 Participants	32 Participants n=81 Participants	72 Participants n=164 Participants
Sex: Female, Male Male	43 Participants n=83 Participants	49 Participants n=81 Participants	92 Participants n=164 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=83 Participants	1 Participants n=81 Participants	1 Participants n=164 Participants
Race (NIH/OMB) Asian	0 Participants n=83 Participants	0 Participants n=81 Participants	0 Participants n=164 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=83 Participants	0 Participants n=81 Participants	0 Participants n=164 Participants
Race (NIH/OMB) Black or African American	2 Participants n=83 Participants	5 Participants n=81 Participants	7 Participants n=164 Participants
Race (NIH/OMB) White	81 Participants n=83 Participants	75 Participants n=81 Participants	156 Participants n=164 Participants
Race (NIH/OMB) More than one race	0 Participants n=83 Participants	0 Participants n=81 Participants	0 Participants n=164 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=83 Participants	0 Participants n=81 Participants	0 Participants n=164 Participants
Clinical Dementia Rating-Sum of Boxes (CDR-SB)	2.7 units on a scale STANDARD_DEVIATION 1.1 • n=83 Participants	2.7 units on a scale STANDARD_DEVIATION 1 • n=81 Participants	2.7 units on a scale STANDARD_DEVIATION 1 • n=164 Participants
Mini Mental Status Exam (MMSE)	26 units on a scale STANDARD_DEVIATION 2.2 • n=83 Participants	26.2 units on a scale STANDARD_DEVIATION 2.1 • n=81 Participants	26.1 units on a scale STANDARD_DEVIATION 2.1 • n=164 Participants
Functional Activities Questionnaire (FAQ)	7.0 units on a scale STANDARD_DEVIATION 5.2 • n=81 Participants • Baseline FAQ measure not collected for 7 subjects.	7.6 units on a scale STANDARD_DEVIATION 5.5 • n=76 Participants • Baseline FAQ measure not collected for 7 subjects.	7.3 units on a scale STANDARD_DEVIATION 5.4 • n=157 Participants • Baseline FAQ measure not collected for 7 subjects.

PRIMARY outcome

Timeframe: 78 weeks

Outcome measures

Outcome measures
Measure	Placebo Oral Tablet n=83 Participants Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Placebo Oral Tablet: Placebo oral tablet	AGB101 220 mg Tablet n=81 Participants Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. AGB101 220 mg tablet: 220 mg AGB101 active compound
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline	1.1 score on a scale Standard Deviation 2	.9 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 78 weeks

MMSE scores at baseline were subtracted from MMSE scores at week 78 to generate the change score from baseline, with a possible total range of -30 to 30. Positive change scores reflect improved performance on the MMSE at week 78, while negative change scores reflect worsening performance on the MMSE at week 78.

Outcome measures

Outcome measures
Measure	Placebo Oral Tablet n=83 Participants Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Placebo Oral Tablet: Placebo oral tablet	AGB101 220 mg Tablet n=81 Participants Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. AGB101 220 mg tablet: 220 mg AGB101 active compound
Change in Mini Mental Status Exam (MMSE) Score From Baseline	-1.9 units on a scale Standard Deviation 3.7	-2.2 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 78 weeks

FAQ scores at baseline were subtracted from FAQ scores at week 78 to generate the change score from baseline, with a possible total range of -30 to 30. Positive change scores reflect greater impairment on the FAQ at week 78, while negative change scores reflect less impairment on the FAQ at week 78.

Outcome measures

Outcome measures
Measure	Placebo Oral Tablet n=83 Participants Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Placebo Oral Tablet: Placebo oral tablet	AGB101 220 mg Tablet n=81 Participants Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. AGB101 220 mg tablet: 220 mg AGB101 active compound
Change in Functional Activities Questionnaire (FAQ) Score From Baseline	3.6 units on a scale Standard Deviation 6.4	4 units on a scale Standard Deviation 5.3

Adverse Events

Placebo Oral Tablet

Serious events: 10 serious events

Other events: 49 other events

Deaths: 0 deaths

AGB101 220 mg Tablet

Serious events: 13 serious events

Other events: 40 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Richard Mohs

agenebio

Phone: 317-997-3241

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo Oral Tablet n=83 participants at risk Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Placebo Oral Tablet: Placebo oral tablet	AGB101 220 mg Tablet n=78 participants at risk Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. AGB101 220 mg tablet: 220 mg AGB101 active compound
Cardiac disorders Acute myocardial infarction	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Cardiac disorders Atrial fibrillation	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Cardiac disorders Atrioventricular block second degree	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Cardiac disorders Bradycardia	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Cardiac disorders Coronary artery disease	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Cardiac disorders Coronary artery occlusion	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Cardiac disorders Sinus node dysfunction	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	3.8% 3/78 • Number of events 3 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Infections and infestations Appendicitis	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Infections and infestations Cystitis	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Infections and infestations Pneumonia legionella	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Infections and infestations Sepsis	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Injury, poisoning and procedural complications Hip fracture	2.4% 2/83 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Injury, poisoning and procedural complications Joint injury	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Nervous system disorders Seizure	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	2.6% 2/78 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Nervous system disorders Transient ischemic attack	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Vascular disorders Hypertension	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Vascular disorders Hypertensive crisis	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Vascular disorders Hypertensive urgency	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.

Measure	Placebo Oral Tablet n=83 participants at risk Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks. Placebo Oral Tablet: Placebo oral tablet	AGB101 220 mg Tablet n=78 participants at risk Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks. AGB101 220 mg tablet: 220 mg AGB101 active compound
Blood and lymphatic system disorders Blood and lymphatic system disorders	8.4% 7/83 • Number of events 8 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	2.6% 2/78 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Cardiac disorders cardiac disorders	3.6% 3/83 • Number of events 7 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 5 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Ear and labyrinth disorders Ear and labyrinth disorders	2.4% 2/83 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Endocrine disorders Endocrine disorders	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Eye disorders Eye disorders	3.6% 3/83 • Number of events 3 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Gastrointestinal disorders Gastrointestinal disorders	15.7% 13/83 • Number of events 18 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	9.0% 7/78 • Number of events 10 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
General disorders General disorders and administration site condition	12.0% 10/83 • Number of events 14 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	6.4% 5/78 • Number of events 5 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Hepatobiliary disorders Hepatobiliary disorders	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Infections and infestations Infections and infestations	15.7% 13/83 • Number of events 19 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	14.1% 11/78 • Number of events 12 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	18.1% 15/83 • Number of events 31 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	15.4% 12/78 • Number of events 18 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Investigations Investigations	9.6% 8/83 • Number of events 8 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	9.0% 7/78 • Number of events 7 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Metabolism and nutrition disorders Metabolism and nutrition disorders	7.2% 6/83 • Number of events 7 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	6.4% 5/78 • Number of events 7 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	24.1% 20/83 • Number of events 31 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	14.1% 11/78 • Number of events 14 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (inc cysts and polyps)	3.6% 3/83 • Number of events 9 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	2.6% 2/78 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Nervous system disorders Nervous system disorders	18.1% 15/83 • Number of events 21 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	10.3% 8/78 • Number of events 15 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Product Issues Product issues	0.00% 0/83 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Psychiatric disorders Psychiatric disorders	10.8% 9/83 • Number of events 11 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	17.9% 14/78 • Number of events 21 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Renal and urinary disorders Renal and urinary disorders	2.4% 2/83 • Number of events 5 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Reproductive system and breast disorders Reproductive system and breast disorders	2.4% 2/83 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	4.8% 4/83 • Number of events 6 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	2.6% 2/78 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	8.4% 7/83 • Number of events 7 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	2.6% 2/78 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Social circumstances Social circumstances	1.2% 1/83 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	0.00% 0/78 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Surgical and medical procedures Surgical and medical procedures	1.2% 1/83 • Number of events 2 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.
Vascular disorders Vascular disorders	8.4% 7/83 • Number of events 7 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.	1.3% 1/78 • Number of events 1 • 18 months Three subjects were randomized and assigned to receive AGB101 but were not treated, lowering the total number of at risk participants treated with AGB101 to 78.