Trial Outcomes & Findings for Special Investigation of COMIRNATY in the Population With Underlying Diseases (NCT NCT04880447)
NCT ID: NCT04880447
Last Updated: 2024-06-21
Results Overview
An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2.
Recruitment status
COMPLETED
Target enrollment
1075 participants
Primary outcome timeframe
From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
Results posted on
2024-06-21
Participant Flow
Participant milestones
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
|
|---|---|
|
Overall Study
STARTED
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1075
|
|
Overall Study
COMPLETED
|
1038
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
|
Overall Study
No vaccination information
|
1
|
|
Overall Study
No adverse event information (missing information)
|
1
|
|
Overall Study
Disease not covered in this study
|
35
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
n=1038 Participants
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
|
Age, Customized
<15 years
|
3 Participants
n=1038 Participants
|
|
Age, Customized
≥15 and <65 years
|
568 Participants
n=1038 Participants
|
|
Age, Customized
≥65 years
|
467 Participants
n=1038 Participants
|
|
Sex: Female, Male
Female
|
433 Participants
n=1038 Participants
|
|
Sex: Female, Male
Male
|
605 Participants
n=1038 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2.
Outcome measures
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
n=1038 Participants
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
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Proportion of Participants With Adverse Reactions
Overall observation period
|
59 Participants
|
|
Proportion of Participants With Adverse Reactions
Observation from the 1st to the 2nd vaccination
|
30 Participants
|
|
Proportion of Participants With Adverse Reactions
Observation from 2nd vaccination to 28 days
|
39 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. The proportion of serious adverse reactions was presented for the overall observation period, the observation period from the first to the second vaccination, and the observation period from the date of Dose 1 up to 28 days after Dose 2.
Outcome measures
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
n=1038 Participants
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
|
Proportion of Participants With Serious Adverse Reactions
Overall observation period
|
3 Participants
|
|
Proportion of Participants With Serious Adverse Reactions
Observation from the 1st to the 2nd vaccination
|
1 Participants
|
|
Proportion of Participants With Serious Adverse Reactions
Observation from 2nd vaccination to 28 days
|
2 Participants
|
PRIMARY outcome
Timeframe: Within 8 days after the date of the first dose.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the first vaccination was collected from 1035 participants of the 1038 safety analysis set participants.
Outcome measures
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
n=1035 Participants
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
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Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination)
Local reactions
|
836 Participants
|
|
Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination)
Systemic reactions
|
648 Participants
|
PRIMARY outcome
Timeframe: Within 8 days after the date of the second dose.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once.
Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the second vaccination was collected from 1026 participants of the 1032 participants who received the second vaccination with Comirnaty.
Outcome measures
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
n=1026 Participants
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
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Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination)
Local reactions
|
866 Participants
|
|
Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination)
Systemic reactions
|
716 Participants
|
Adverse Events
COMIRNATY Intramuscular Injection (Tozinameran)
Serious events: 11 serious events
Other events: 114 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
n=1038 participants at risk
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
|
Cardiac disorders
Angina unstable
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Bacteraemia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
Other adverse events
| Measure |
COMIRNATY Intramuscular Injection (Tozinameran)
n=1038 participants at risk
Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2.
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|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Cardiac disorders
Palpitations
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Cardiac disorders
Tachycardia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Eye disorders
Conjunctivitis allergic
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Eye disorders
Ocular hyperaemia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
4/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
4/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Faeces soft
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Axillary pain
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Injection site bruising
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Injection site paraesthesia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Injection site pruritus
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Malaise
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Oedema
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Oedema peripheral
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Pain
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Peripheral swelling
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Pyrexia
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Thirst
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Vaccination site pruritus
|
0.39%
4/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
General disorders
Vaccination site rash
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Abscess limb
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
COVID-19
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Cystitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.48%
5/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Otitis externa
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Parotitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Pharyngitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Tonsillitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.39%
4/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Investigations
Blood pressure decreased
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Investigations
Blood pressure increased
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Investigations
Brain natriuretic peptide increased
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Dizziness
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Headache
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Somnolence
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Nervous system disorders
Taste disorder
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.29%
3/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic eosinophilic rhinosinusitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.39%
4/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
4/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.19%
2/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
|
Vascular disorders
Hot flush
|
0.10%
1/1038 • From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.
|
Additional Information
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.
- Publication restrictions are in place
Restriction type: OTHER