Trial Outcomes & Findings for Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV (NCT NCT05781542)
NCT ID: NCT05781542
Last Updated: 2025-11-14
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Group T1
0.5mg INO-6172 (m0,1,3)
|
Group T2
2mg INO-6172 (m0,1,3)
|
Group T3
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
18
|
18
|
|
Overall Study
Safety Population
|
10
|
18
|
18
|
|
Overall Study
COMPLETED
|
9
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group T1
0.5mg INO-6172 (m0,1,3)
|
Group T2
2mg INO-6172 (m0,1,3)
|
Group T3
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV
Baseline characteristics by cohort
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 years
n=10 Participants
|
25.5 years
n=10 Participants
|
24 years
n=20 Participants
|
25 years
n=45 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Age, Customized
18 - 20 years
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Age, Customized
21 - 30 years
|
5 Participants
n=10 Participants
|
12 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
27 Participants
n=45 Participants
|
|
Age, Customized
31 - 40 years
|
3 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
10 Participants
n=45 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Age, Customized
Above 50 years
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
18 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
28 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
41 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=10 Participants
|
14 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
27 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
17 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Region of Enrollment
South Africa
|
3 Participants
n=10 Participants
|
14 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
26 Participants
n=45 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
20 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/AlumPopulation: Started (enrolled).
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
None
|
3 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Mild
|
6 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/AlumPopulation: Started (enrolled).
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
8 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
8 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
8 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/AlumPopulation: Started (enrolled).
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Myalgia · Severe
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Headache · Mild
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Headache · Moderate
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Headache · Severe
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Chills · Mild
|
0 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Chills · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Temperature · Mild
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Temperature · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Malaise and/or fatigue · Mild
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Malaise and/or fatigue · Moderate
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Malaise and/or fatigue · Severe
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Myalgia · None
|
9 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Headache · None
|
7 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Nausea · None
|
9 Participants
|
14 Participants
|
9 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Chills · Severe
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Arthralgia · None
|
9 Participants
|
16 Participants
|
7 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Max. Systemic Symptoms · None
|
6 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Max. Systemic Symptoms · Mild
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Max. Systemic Symptoms · Moderate
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Temperature · None
|
10 Participants
|
17 Participants
|
13 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Malaise and/or fatigue · None
|
7 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Myalgia · Mild
|
1 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Nausea · Mild
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Nausea · Moderate
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Chills · None
|
10 Participants
|
14 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Arthralgia · Mild
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Max. Systemic Symptoms · Severe
|
0 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured for 30 days after any receipt of study vaccinationPopulation: Started (enrolled).
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Moderate
|
5 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Mild
|
0 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12 following any receipt of study productsPopulation: Started (enrolled).
The number (percentage) of Participants Reporting Medically Attended Adverse Events (MAAEs) was summarized by arm and severity grade
Outcome measures
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), by Severity Grade
Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), by Severity Grade
Moderate
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), by Severity Grade
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), by Severity Grade
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12 following any receipt of study productsPopulation: Started (enrolled).
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Outcome measures
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Unable to contact participant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Protocol deviation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Did not discontinue SPA
|
9 Participants
|
17 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12 following any receipt of study productsPopulation: Started (enrolled).
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Outcome measures
| Measure |
Group T1
n=10 Participants
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 Participants
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 Participants
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Unable to contact participant
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Scheduled exit visit/end of study
|
9 Participants
|
18 Participants
|
17 Participants
|
Adverse Events
Group T1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group T2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group T3
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group T1
n=10 participants at risk
0.5mg INO-6172 (m0,1,3)
|
Group T2
n=18 participants at risk
2mg INO-6172 (m0,1,3)
|
Group T3
n=18 participants at risk
2mg INO-6172 (m0,1,3), 100mcg Trimer 4571 + 5mcg 3M-052 AF/500 mcg Alum (m3,6)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Blood and lymphatic system disorders
Lymph node pain
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Cardiac disorders
Arrhythmia
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Eye disorders
Blepharitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
22.2%
4/18 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
9/18 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Chills (Solicited)
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
22.2%
4/18 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
72.2%
13/18 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Cyst
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injection site erythema (Solicited)
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
27.8%
5/18 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
27.8%
5/18 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injection site pain (Solicited)
|
70.0%
7/10 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
9/18 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
77.8%
14/18 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injection site pruritus
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injection site swelling (Solicited)
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
2/18 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
2/18 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Malaise (Solicited)
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
44.4%
8/18 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
77.8%
14/18 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Abscess limb
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
2/18 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Gingivitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Herpes simplex
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Impetigo
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Syphilis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Tooth abscess
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Concussion
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
2/18 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Body temperature increased (Solicited)
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
27.8%
5/18 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
2/18 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Solicited)
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
2/18 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
61.1%
11/18 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
27.8%
5/18 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
72.2%
13/18 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Cervical radiculopathy
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Headache (Solicited)
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
38.9%
7/18 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
72.2%
13/18 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Social circumstances
Victim of sexual abuse
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.6%
1/18 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months.
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place