Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults (NCT NCT05184062)

NCT ID: NCT05184062

Last Updated: 2024-11-21

Results Overview

Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 272 participants
• Primary outcome timeframe: recorded from the time of signature of the ICF up to 245 days
• Results posted on: 2024-11-21

Participant Flow

Participant milestones

Measure	AZD7442 AZD7442 600 mg IV	Placebo Placebo Group
Overall Study STARTED	202	70
Overall Study COMPLETED	196	69
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Measure	AZD7442 AZD7442 600 mg IV	Placebo Placebo Group
Overall Study Lost to Follow-up	5	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety Analysis Set

Baseline characteristics by cohort

Measure	AZD7442 n=202 Participants AZD7442 600 mg IV	Placebo n=70 Participants Placebo Group	Total n=272 Participants Total of all reporting groups
Age, Continuous	33.67 Years STANDARD_DEVIATION 11.73 • n=5 Participants	35.71 Years STANDARD_DEVIATION 12.05 • n=7 Participants	34.2 Years STANDARD_DEVIATION 11.80 • n=5 Participants
Age, Customized >60 years	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Age, Customized 18 - 44 years	170 Participants n=5 Participants	54 Participants n=7 Participants	224 Participants n=5 Participants
Age, Customized 45 -60 years	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants • Safety Analysis Set	22 Participants n=7 Participants • Safety Analysis Set	84 Participants n=5 Participants • Safety Analysis Set
Sex: Female, Male Male	140 Participants n=5 Participants • Safety Analysis Set	48 Participants n=7 Participants • Safety Analysis Set	188 Participants n=5 Participants • Safety Analysis Set
Race/Ethnicity, Customized Asian	202 Participants n=5 Participants	70 Participants n=7 Participants	272 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	202 Participants n=5 Participants	70 Participants n=7 Participants	272 Participants n=5 Participants
COVID-19 vaccination status No, non-vaccinated	98 Participants n=5 Participants	34 Participants n=7 Participants	132 Participants n=5 Participants
COVID-19 vaccination status Yes, vaccinated	104 Participants n=5 Participants	36 Participants n=7 Participants	140 Participants n=5 Participants
Baseline Weight	67.26 kg STANDARD_DEVIATION 11.54 • n=5 Participants	66.51 kg STANDARD_DEVIATION 9.91 • n=7 Participants	67.07 kg STANDARD_DEVIATION 11.13 • n=5 Participants
Baseline Height	167.50 cm STANDARD_DEVIATION 8.77 • n=5 Participants	166.53 cm STANDARD_DEVIATION 7.78 • n=7 Participants	167.25 cm STANDARD_DEVIATION 8.53 • n=5 Participants
Baseline Body Mass Index	23.84 kg/m^2 STANDARD_DEVIATION 3.14 • n=5 Participants	23.91 kg/m^2 STANDARD_DEVIATION 2.96 • n=7 Participants	23.86 kg/m^2 STANDARD_DEVIATION 3.09 • n=5 Participants

PRIMARY outcome

Timeframe: recorded from the time of signature of the ICF up to 245 days

Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.

Outcome measures

Measure	AZD7442 n=202 Participants AZD7442 600 mg IV	Placebo n=70 Participants Placebo Group
Adverse Events of Special Interest	0 Participants	0 Participants

SECONDARY outcome

Timeframe: recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.

Population: All participants who received AZD7442 and had at least one quantifiable serum PK observation post-dose, with no important protocol deviations thought to impact the analysis of the PK data

Serum concentrations for each scheduled time point are summarized based on the PK Analyses Set using descriptive statistics

Outcome measures

Measure	AZD7442 n=202 Participants AZD7442 600 mg IV	Placebo Placebo Group
Serum Concentrations of AZD7442 Over Time pre-dose	0 μg/mL Standard Deviation 0	—
Serum Concentrations of AZD7442 Over Time Day 1	219.7 μg/mL Standard Deviation 37.81	—
Serum Concentrations of AZD7442 Over Time Day 8	136.1 μg/mL Standard Deviation 26.58	—
Serum Concentrations of AZD7442 Over Time Day 31	101.5 μg/mL Standard Deviation 19.99	—
Serum Concentrations of AZD7442 Over Time Day 61	74.60 μg/mL Standard Deviation 16.08	—
Serum Concentrations of AZD7442 Over Time Day 91	55.98 μg/mL Standard Deviation 12.82	—
Serum Concentrations of AZD7442 Over Time Day 181	28.92 μg/mL Standard Deviation 7.752	—
Serum Concentrations of AZD7442 Over Time Day 271	12.74 μg/mL Standard Deviation 4.186	—
Serum Concentrations of AZD7442 Over Time Day 361	5.858 μg/mL Standard Deviation 2.530	—

Adverse Events

AZD7442

Serious events: 6 serious events

Other events: 144 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Measure	AZD7442 n=202 participants at risk AZD7442 600 mg IV	Placebo n=70 participants at risk Placebo Group
Injury, poisoning and procedural complications Radius fracture	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Metabolism and nutrition disorders Hypokalaemia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Covid-19 pneumonia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Thermal burn	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Eye disorders Retinal detachment	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Laryngopharyngitis	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.

Other adverse events

Measure	AZD7442 n=202 participants at risk AZD7442 600 mg IV	Placebo n=70 participants at risk Placebo Group
Gastrointestinal disorders Diarrhoea	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Reproductive system and breast disorders Menstruation delayed	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Cough	3.5% 7/202 • Number of events 7 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.0% 6/202 • Number of events 7 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Acne	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Dermatitis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Enteritis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Rash	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Skin exfoliation	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Vascular disorders Hypertension	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Vascular disorders Hypotension	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Gastritis	0.50% 1/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Haemorrhoids	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Lip blister	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Mouth ulceration	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Noninfective gingivitis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Tooth impacted	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Toothache	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Blood and lymphatic system disorders Eosinophilia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Vomiting	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Asthenia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Discomfort	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Fatigue	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Infusion site oedema	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Infusion site swelling	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Malaise	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Pain	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Pyrexia	3.5% 7/202 • Number of events 7 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Hepatobiliary disorders Cholelithiasis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Cardiac disorders Nodal rhythm	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Hepatobiliary disorders Hepatic function abnormal	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Hepatobiliary disorders Hyperbilirubinaemia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Immune system disorders Drug hypersensitivity	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Immune system disorders Hypersensitivity	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Immune system disorders Seasonal allergy	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Asymptomatic bacteriuria	0.50% 1/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Cervicitis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Conjunctivitis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Cardiac disorders Sinus bradycardia	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Erysipelas	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Folliculitis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Gastroenteritis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Gingivitis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Herpes simplex	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Herpes zoster	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Nasopharyngitis	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	5.7% 4/70 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Oral herpes	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Pericoronitis	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Respiratory tract infection	2.0% 4/202 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Ear and labyrinth disorders Otolithiasis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Sinusitis	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Tinea cruris	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Tonsillitis	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Upper respiratory tract infection	14.4% 29/202 • Number of events 36 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	18.6% 13/70 • Number of events 15 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Urinary tract infection	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Animal bite	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Fall	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Heat stroke	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Joint dislocation	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Eye disorders Keratitis	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Limb injury	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Mouth injury	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Skin abrasion	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Alanine aminotransferase increased	2.0% 4/202 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Aspartate aminotransferase increased	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Blood bilirubin increased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Blood creatine phosphokinase increased	4.0% 8/202 • Number of events 8 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	4.3% 3/70 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Blood glucose increased	2.0% 4/202 • Number of events 7 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Abdominal pain	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Blood pressure increased	0.99% 2/202 • Number of events 6 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Blood urine present	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations C-reactive protein increased	2.0% 4/202 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Gamma-glutamyltransferase increased	1.5% 3/202 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Lymphocyte count decreased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Monocyte count increased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Neutrophil count decreased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Neutrophil count increased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Platelet count increased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Protein urine present	7.4% 15/202 • Number of events 17 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	12.9% 9/70 • Number of events 10 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Abdominal pain upper	0.50% 1/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Qrs axis abnormal	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Bile acids increased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations White blood cell count decreased	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	4.3% 3/70 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations White blood cell count increased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Metabolism and nutrition disorders Hyperphagia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Musculoskeletal and connective tissue disorders Back pain	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Musculoskeletal and connective tissue disorders Groin pain	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Aphthous ulcer	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Musculoskeletal and connective tissue disorders Neck pain	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Nervous system disorders Dizziness	1.5% 3/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Nervous system disorders Headache	2.5% 5/202 • Number of events 5 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	5.7% 4/70 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Psychiatric disorders Insomnia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Renal and urinary disorders Albuminuria	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Renal and urinary disorders Calculus urinary	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Renal and urinary disorders Haematuria	0.99% 2/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	2.9% 2/70 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Renal and urinary disorders Proteinuria	0.99% 2/202 • Number of events 3 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Renal and urinary disorders Urine abnormality	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Flatulence	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Gastrointestinal disorders Glossodynia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Cystic lung disease	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Alopecia	2.0% 4/202 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Skin and subcutaneous tissue disorders Seborrhoeic alopecia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Blood and lymphatic system disorders Anaemia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Chest pain	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
General disorders Influenza like illness	9.9% 20/202 • Number of events 20 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	5.7% 4/70 • Number of events 4 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Hepatobiliary disorders Gallbladder polyp	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Hepatobiliary disorders Hepatic calcification	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Cardiac disorders Supraventricular tachycardia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Cardiac disorders Ventricular extrasystoles	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations COVID-19	28.7% 58/202 • Number of events 58 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	28.6% 20/70 • Number of events 20 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations COVID-19 pneumonia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Hordeolum	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Infection parasitic	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Otitis media	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Pelvic inflammatory disease	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Pharyngitis	0.99% 2/202 • Number of events 2 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Pneumonia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Infections and infestations Suspected COVID-19	5.9% 12/202 • Number of events 12 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	20.0% 14/70 • Number of events 14 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Ear and labyrinth disorders Vertigo	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Contusion	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Joint injury	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Injury, poisoning and procedural complications Scratch	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Eye disorders Cataract	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Electrocardiogram T wave abnormal	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Myocardial necrosis marker increased	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Ultrasound liver abnormal	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Platelet count decreased	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations Red blood cell count decreased	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Investigations White blood cells urine positive	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Metabolism and nutrition disorders Glucose tolerance impaired	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Metabolism and nutrition disorders Hyperuricaemia	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Psychiatric disorders Alcoholism	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Psychiatric disorders Sleep disorder	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Renal and urinary disorders Pollakiuria	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Reproductive system and breast disorders Balanoposthitis	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Congenital, familial and genetic disorders Type V hyperlipidaemia	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Endocrine disorders Hyperadrenocorticism	0.00% 0/202 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	1.4% 1/70 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Endocrine disorders Hyperthyroidism	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.
Social circumstances Alcohol use	0.50% 1/202 • Number of events 1 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.	0.00% 0/70 • Adverse events were recorded from the time of signature of the informed consent form up to 445 days.

Additional Information

AstraZeneca Clinical Study Information Center

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

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