Trial Outcomes & Findings for Open-Label Extension of Voxelotor (NCT NCT04188509)

Last Updated: 2025-11-13

Results Overview

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. AEs included both serious AEs (SAEs) and all non-SAEs. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

162 participants

Primary outcome timeframe

From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years)

Results posted on

2025-11-13

Participant Flow

A total of 162 participants who had previously completed the following studies: GBT440-032 (NCT04218084) who received placebo, and GBT440-007 (NCT02850406), GBT440-032 (NCT04218084) or GBT440-042 (NCT05561140) who received voxelotor were enrolled in the study GBT440-038 (NCT04188509). All participants enrolled in this study received voxelotor.

Participant milestones

Participant milestones
Measure	Voxelotor Participants aged \>= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Overall Study STARTED	162
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	137

Reasons for withdrawal

Reasons for withdrawal
Measure	Voxelotor Participants aged \>= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	1
Overall Study Withdrawal of Consent	1
Overall Study Discretion of Investigator	1
Overall Study Noncompliance	3
Overall Study Sponsor Decision	127
Overall Study Other	2

Baseline Characteristics

Open-Label Extension of Voxelotor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voxelotor n=162 Participants Participants aged \>= 12 years received voxelotor 1500 mg QD tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Age, Continuous	9.2 Years STANDARD_DEVIATION 5.68 • n=10 Participants
Sex: Female, Male Female	75 Participants n=10 Participants
Sex: Female, Male Male	87 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	161 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race/Ethnicity, Customized Race · African	94 Participants n=10 Participants
Race/Ethnicity, Customized Race · Arab	2 Participants n=10 Participants
Race/Ethnicity, Customized Race · Black or African American	40 Participants n=10 Participants
Race/Ethnicity, Customized Race · Middle Eastern or North African	9 Participants n=10 Participants
Race/Ethnicity, Customized Race · White	10 Participants n=10 Participants
Race/Ethnicity, Customized Race · Multi-Racial	7 Participants n=10 Participants

PRIMARY outcome

Timeframe: From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years)

Population: The safety population included all participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Voxelotor n=162 Participants Participants aged \>= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Number of Participants With Treatment Emergent Adverse Events (AEs)	105 Participants

PRIMARY outcome

Timeframe: From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years)

Population: The safety population included all participants who received at least 1 dose of study drug.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered to be drug related. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.

Outcome measures

Outcome measures
Measure	Voxelotor n=162 Participants Participants aged \>= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Number of Participants With SAEs	53 Participants

PRIMARY outcome

Timeframe: From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years)

Population: The safety population included all participants who received at least 1 dose of study drug.

SCD-related AEs were common complications associated with the study participant's SCD and were not considered to be related to voxelotor unless judged by the investigator to have worsened in severity and/or frequency or changed in nature during the study. SCD-related complications included the following: sickle cell anemia with crisis, acute chest syndrome (ACS), pneumonia, priapism, and osteonecrosis. A treatment emergent AE was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. An SAE was an AE or suspected adverse reaction that, at any dose, in the view of either the investigator or sponsor, resulted in any of the following outcomes: death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.

Outcome measures

Outcome measures
Measure	Voxelotor n=162 Participants Participants aged \>= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs SCD related treatment emergent AE	60 Participants
Number of Participants With Sickle Cell Disease (SCD) Related TEAEs and SAEs SCD related SAEs	43 Participants

Adverse Events

Voxelotor

Serious events: 53 serious events

Other events: 93 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Voxelotor n=162 participants at risk Participants aged \>= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	21.6% 35/162 • Number of events 75 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	9.9% 16/162 • Number of events 41 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Splenic sequestration crisis	3.1% 5/162 • Number of events 7 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Haemolysis	0.62% 1/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Urethral valves	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	2.5% 4/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Pyrexia	4.9% 8/162 • Number of events 9 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Chills	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Malaria	4.9% 8/162 • Number of events 8 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Sepsis	3.7% 6/162 • Number of events 9 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	1.9% 3/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	1.9% 3/162 • Number of events 3 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Atypical pneumonia	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Coronavirus infection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Influenza	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Tonsillitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Wound sepsis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Acute haemolytic transfusion reaction	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Liver function test increased	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Nervous system disorders Headache	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Priapism	0.62% 1/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	9.3% 15/162 • Number of events 20 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.2% 2/162 • Number of events 6 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Vascular disorders Thrombophlebitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Voxelotor n=162 participants at risk Participants aged \>= 12 years received voxelotor 1500 milligrams (mg) once daily (QD) tablets. Participants aged \< 12 years received a voxelotor dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg QD as powder for oral suspension or dispersible tablet or modified dispersible tablet. Participants received study drug as long they continued to receive clinical benefit that outweighed risk as determined by the investigator and/or until the participant had access to voxelotor from an alternative source.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	16.7% 27/162 • Number of events 53 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	5.6% 9/162 • Number of events 12 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytosis	3.7% 6/162 • Number of events 6 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	1.9% 3/162 • Number of events 3 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Splenic sequestration crisis	1.2% 2/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Cytopenia	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Hypersplenism	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Macrocytosis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Splenomegaly	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Cardiac disorders Bradycardia	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Cholesteatoma	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Eye disorders Vernal keratoconjunctivitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	3.7% 6/162 • Number of events 11 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	3.7% 6/162 • Number of events 6 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	2.5% 4/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	2.5% 4/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	1.9% 3/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Salivary hypersecretion	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Anal pruritus	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Peptic ulcer	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Gastrointestinal disorders Toothache	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Pyrexia	12.3% 20/162 • Number of events 32 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	1.9% 3/162 • Number of events 7 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Decreased activity	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Pain	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
General disorders Swelling face	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatosplenomegaly	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	8.0% 13/162 • Number of events 25 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Malaria	6.2% 10/162 • Number of events 11 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	3.1% 5/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Influenza	3.1% 5/162 • Number of events 6 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations COVID-19	2.5% 4/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	2.5% 4/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Tonsillitis	2.5% 4/162 • Number of events 7 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Viral infection	2.5% 4/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	1.9% 3/162 • Number of events 6 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	1.2% 2/162 • Number of events 3 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Adenovirus infection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Body tinea	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Bronchitis viral	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Coronavirus infection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Croup infectious	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Diarrhoea infectious	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Enterovirus infection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis viral	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Hordeolum	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Mumps	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Otitis media	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Periorbital cellulitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Pharyngotonsillitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Respiratory syncytial virus infection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Rhinitis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Sepsis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Skin candida	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Staphylococcal bacteraemia	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Infections and infestations Varicella	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint injury	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Head injury	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Lip injury	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic pain	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Platelet count increased	3.1% 5/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Eosinophil count increased	2.5% 4/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Red cell distribution width abnormal	1.9% 3/162 • Number of events 3 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Blood calcium decreased	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Blood urea decreased	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Haemoglobin decreased	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Platelet count decreased	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Bilirubin conjugated increased	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations Mean cell volume decreased	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Investigations SARS-CoV-2 test positive	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	5.6% 9/162 • Number of events 9 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Abnormal loss of weight	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 6/162 • Number of events 8 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 4/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	1.2% 2/162 • Number of events 4 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Nervous system disorders Headache	3.7% 6/162 • Number of events 9 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Nervous system disorders Cluster headache	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Nervous system disorders Migraine	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Renal and urinary disorders Hypertonic bladder	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Painful erection	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Priapism	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 5/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.5% 4/162 • Number of events 5 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	1.2% 2/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.62% 1/162 • Number of events 2 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Surgical and medical procedures Splenectomy	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.
Vascular disorders Pallor	0.62% 1/162 • Number of events 1 • From date of informed consent until 28 days after last dose of study drug (maximum up to 4.31 years) Same events may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population included all participants who received at least one dose of study drug.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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