Trial Outcomes & Findings for Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes (NCT NCT03895996)

NCT ID: NCT03895996

Last Updated: 2025-03-05

Results Overview

Treatment-emergent AEs (TEAEs) are defined as any AE that started on or after the first dose of study medication through 30 days following the last dose.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: At the Primary Analysis (when all the patients have completed their Day 150 visit)
• Results posted on: 2025-03-05

Participant Flow

Participant milestones

Measure	AVT001 (Treatment) Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo Infusion of AVT001-matched placebo Placebo: matched placebo
Overall Study STARTED	16	9
Overall Study Leukapheresed and Dosed	16	9
Overall Study Primary Analysis at Day 150	16	9
Overall Study Supplemental Analysis at Day 360	16	8
Overall Study COMPLETED	16	8
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes

Baseline characteristics by cohort

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo	Total n=25 Participants Total of all reporting groups
Age, Continuous	26.5 years STANDARD_DEVIATION 9.0 • n=5 Participants	26.2 years STANDARD_DEVIATION 6.2 • n=7 Participants	26.4 years STANDARD_DEVIATION 8.0 • n=5 Participants
Age, Customized Age by Category · <18	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized Age by Category · 18-<25	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Age, Customized Age by Category · 25-<40	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Customized Age by Category · 40-<60	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the Primary Analysis (when all the patients have completed their Day 150 visit)

Population: The safety (SAF) population is defined as all subjects who receive at least one dose of study medication.

Treatment-emergent AEs (TEAEs) are defined as any AE that started on or after the first dose of study medication through 30 days following the last dose.

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Number of Participants With Treatment-emergent Adverse Events (TEAE) Participants with Any TEAE	9 participants	6 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Neutrophil count decreased	4 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Hyponatraemia	3 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Cough	3 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) White blood cell count decreased	2 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Ear pain	2 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Lymphocyte count decreased	2 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Anaemia	1 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Blood bicarbonate decreased	1 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Blood bilirubin increased	1 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Corona virus infection	1 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Chills	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Gastrooesophageal reflux disease	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Joint dislocation	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Nasal congestion	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Non-cardiac chest pain	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Oropharyngeal pain	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Sinusitis	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Headache	0 participants	2 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Blood potassium decreased	0 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Influenza like illness	0 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Nausea	0 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Oral papule	0 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Upper-airway cough syndrome	0 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Dizziness	1 participants	2 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Fatigue	1 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Hypocalcaemia	1 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Pyrexia	1 participants	1 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Palpitations	1 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Gastroenteritis	0 participants	1 participants

PRIMARY outcome

Timeframe: 5 months post first dose

Population: The safety (SAF) population is defined as all subjects who receive at least one dose of study medication.

Number of Participants and severity of local intravenous site reactions after receiving the three doses are reported.

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Number of Participants and Severity of Local i.v.-Site Reactions,	0 Number of patients	0 Number of patients

PRIMARY outcome

Timeframe: 5 months post first dose

Population: The safety (SAF) population is defined as all subjects who receive at least one dose of study medication.

Safety/tolerability outcomes - creatinine

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Changes From Baseline of Creatinine	1.9338 umol/L Standard Deviation 7.51638	0.4911 umol/L Standard Deviation 5.48705

PRIMARY outcome

Timeframe: 5 months post first dose

Population: The safety (SAF) population is defined as all subjects who receive at least one dose of study medication.

Safety/tolerability outcomes - Aspartate Aminotransferase

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Changes From Baseline of Aspartate Aminotransferase	-1.9 U/L Standard Deviation 7.76	2.2 U/L Standard Deviation 6.10

PRIMARY outcome

Timeframe: 5 months post first dose

Population: The safety (SAF) population is defined as all subjects who receive at least one dose of study medication.

Safety/tolerability outcomes - Alanine Aminotransferase

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Changes From Baseline of Alanine Aminotransferase	-0.1 U/L Standard Deviation 5.21	1.1 U/L Standard Deviation 3.26

PRIMARY outcome

Timeframe: 5 months post first dose

Population: The safety (SAF) population is defined as all subjects who receive at least one dose of study medication.

Safety/tolerability outcomes - Total Bilirubin

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Changes From Baseline of Total Bilirubin	-0.114 umol/L Standard Deviation 4.0603	0.000 umol/L Standard Deviation 4.0103

SECONDARY outcome

Timeframe: 5 months post first dose

Population: The pharmacodynamic (PD) population is defined as all subjects in the safety population with at least one post-baseline assessment for the evaluation of the CD8+ T-cell reg system biomarker.

CD8+ T cell Inhibition Assay is used to determine whether AVT001 corrects the defect of the dysfunctional Q/E CD8+ Treg pathway in T1D patients. More specifically, this assay detects the specific recognition between the TCR on patients' Q/E CD8+Treg cells and the "common target structure", the HLA-E/Hsp60sp complex, expressed on the surface of the artificially established target cells.

The % inhibition measures the function of down-regulation by Q/E CD8+ Tregs via comparing the % of inhibition of TH1 cells versus TB1 cells.

By assessing the % inhibition of the TH1 cells of the patient's CD8+ T cells, the CD8+ T cell Inhibition Assay detects the specific recognition of the common target structure (HLA-E/Hsp60sp) on TH1 cells by the TCR on the patient's T cells to be tested.

A negative value means the measured Q/E CD8+ Tregs completely lose its inhibition function, and the TH1 cells cultured with it happened to grow faster than the corresponding TB1 cells as its control.

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Assessment of the HLA-E-restricted CD8+ T Cell Regulatory Activity ("Potency Assay") Baseline	-11.2 Percent of Inhibition Standard Deviation 9.9	3.5 Percent of Inhibition Standard Deviation 7.1
Assessment of the HLA-E-restricted CD8+ T Cell Regulatory Activity ("Potency Assay") Visit Day 150	9.3 Percent of Inhibition Standard Deviation 24.9	1.8 Percent of Inhibition Standard Deviation 15.1

SECONDARY outcome

Timeframe: 5 months post first dose

Population: The pharmacodynamic (PD) population is defined as all subjects in the safety population with at least one post-baseline assessment for the evaluation of the CD8+ T-cell reg system biomarker.

The area under the stimulated C-peptide curve (AUC) over the first 4-hour period of a mixed meal glucose tolerance test is calculated using the trapezoidal rule that is a weighted sum of the C-peptide values over the 240 minutes. The AUC is normalized by dividing it with 240 mins, therefore, its unit is nmol/L. Missing C-peptide levels at any given timepoint is not imputed. In the calculation of the AUC when C-peptide levels are missing, a line is drawn from the last timepoint with a non-missing C-peptide to the next timepoint with non-missing C-peptide.

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Changes From Baseline in the Area Under the Curve (AUC) of the Stimulated C-peptide Levels Over a 4-hour Mixed Meal Tolerance Test (MMTT) Baseline	0.531 nmol/L Standard Deviation 0.3628	0.611 nmol/L Standard Deviation 0.1776
Changes From Baseline in the Area Under the Curve (AUC) of the Stimulated C-peptide Levels Over a 4-hour Mixed Meal Tolerance Test (MMTT) Visit Day 150	0.518 nmol/L Standard Deviation 0.4299	0.472 nmol/L Standard Deviation 0.1342

SECONDARY outcome

Timeframe: 5 months post first dose

Population: The pharmacodynamic (PD) population is defined as all subjects in the safety population with at least one post-baseline assessment for the evaluation of the CD8+ T-cell reg system biomarker.

HbA1c is a blood test that is used to monitor blood glucose control in people with diabetes.

HbA1c is short for glycated haemoglobin. The test is also sometimes called haemoglobin A1c.

Outcome measures

Measure	AVT001 (Treatment) n=16 Participants Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 Participants Infusion of AVT001-matched placebo Placebo: matched placebo
Changes From Baseline in HbA1c Baseline	6.0375 % of glycated haemoglobin in the blood Standard Deviation 0.73201	5.6556 % of glycated haemoglobin in the blood Standard Deviation 0.67289
Changes From Baseline in HbA1c Visit Day 150	6.1500 % of glycated haemoglobin in the blood Standard Deviation 0.84538	5.8222 % of glycated haemoglobin in the blood Standard Deviation 0.84080

Adverse Events

AVT001 (Treatment)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Matched Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AVT001 (Treatment) n=16 participants at risk Infusion of AVT001 (treatment) AVT001: autologous dendritic cell therapy	Matched Placebo n=9 participants at risk Infusion of AVT001-matched placebo Placebo: matched placebo
Gastrointestinal disorders Oral papule	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Gastrointestinal disorders Nausea	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations White blood cell count decreased	43.8% 7/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	55.6% 5/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Blood bicarbonate decreased	37.5% 6/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Blood and lymphatic system disorders Anaemia	31.2% 5/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Infections and infestations Corona virus infection	25.0% 4/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	22.2% 2/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 4/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Metabolism and nutrition disorders Hyponatraemia	25.0% 4/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	22.2% 2/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Neutrophil count decreased	25.0% 4/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	33.3% 3/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Aspartate aminotransferase increased	18.8% 3/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Blood alkaline phosphatase increased	18.8% 3/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Metabolism and nutrition disorders Hypocalcaemia	18.8% 3/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Lymphocyte count decreased	18.8% 3/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Blood bilirubin increased	12.5% 2/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	44.4% 4/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Ear and labyrinth disorders Ear pain	12.5% 2/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Infections and infestations Pharyngitis	12.5% 2/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
General disorders Pyrexia	12.5% 2/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Alanine aminotransferase increased	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
General disorders Chills	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Nervous system disorders Dizziness	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	22.2% 2/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
General disorders Fatigue	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Infections and infestations Gastroenteritis	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
General disorders Gastrooesophageal reflux disease	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Nervous system disorders Headache	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	22.2% 2/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Injury, poisoning and procedural complications Hip fracture	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Metabolism and nutrition disorders Hyperkalaemia	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Metabolism and nutrition disorders Hypokalaemia	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Injury, poisoning and procedural complications Joint dislocation	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Monocyte count decreased	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
General disorders Non-cardiac chest pain	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Infections and infestations Otitis media	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Cardiac disorders Palpitations	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Platelet count decreased	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Renal and urinary disorders Proteinuria	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Skin and subcutaneous tissue disorders Pruritus	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Infections and infestations Sinusitis	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	0.00% 0/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Infections and infestations Skin infection	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Gastrointestinal disorders Vomiting	6.2% 1/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Investigations Blood potassium decreased	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Infections and infestations Enterocolitis infectious	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
General disorders Influenza like illness	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/16 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.	11.1% 1/9 • All anticipated and unanticipated adverse events occured during the study (2 years), including both Treatment Emergent Adverse Events (TEAEs) and Post-Treatment Adverse Events (PTAEs), that exceed a 5% frequency threshold within any arm of the clinical study. No difference from the clinicaltrials.gov definitions. There has been no death or SAE events recorded throughout the study, and therefore 0 was reported in the following table.

Additional Information

Tuochuan Dong, Director, Business & Operations

Avotres Inc.

Phone: 7169093370

Email: tuochuan.dong@avotres.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60