Trial Outcomes & Findings for Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults (NCT NCT03844386)

Last Updated: 2022-08-09

Results Overview

The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 will be used to measure safety where Grade 3 is defined as severe and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs will be assessments that are considered related to study product as possible, probable, or definite as defined in the protocol.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

First day of study treatment through 28 days following vaccination

Results posted on

2022-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	MVA.tHIVconsv3 (M3) Participants in this arm receive one vaccine dose of MVA.tHIVconsv3 (M3) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv4 (M4) Participants in this arm receive one vaccine dose of MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) Participants in this arm receive a single combined dose containing each vaccine type MVA.tHIVconsv4 (M3) + MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	Placebo Participants in this arm receive one saline (placebo) dose given IM at Day 0 Placebo: The appropriate amount of Sodium Chloride for Injection USP, 0.9%
Overall Study STARTED	7	7	8	4
Overall Study Completed Day 28	7	7	8	3
Overall Study COMPLETED	7	7	7	3
Overall Study NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVA.tHIVconsv3 (M3) n=7 Participants Participants in this arm receive one vaccine dose of MVA.tHIVconsv3 (M3) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv4 (M4) n=7 Participants Participants in this arm receive one vaccine dose of MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) n=8 Participants Participants in this arm receive a single combined dose containing each vaccine type MVA.tHIVconsv4 (M3) + MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	Placebo n=4 Participants Participants in this arm receive one saline (placebo) dose given IM at Day 0 Placebo: The appropriate amount of Sodium Chloride for Injection USP, 0.9%	Total n=26 Participants Total of all reporting groups
Age, Continuous	43 years n=5 Participants	46 years n=7 Participants	36 years n=5 Participants	29.5 years n=4 Participants	41 years n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	7 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	26 Participants n=21 Participants
Baseline CD4 Cell Count	690 cells/mm^3 n=5 Participants	679 cells/mm^3 n=7 Participants	804.5 cells/mm^3 n=5 Participants	740 cells/mm^3 n=4 Participants	742.5 cells/mm^3 n=21 Participants
Baseline HIV-1 RNA PCR Level	30 copies/ml n=5 Participants	20 copies/ml n=7 Participants	40 copies/ml n=5 Participants	40 copies/ml n=4 Participants	40 copies/ml n=21 Participants

PRIMARY outcome

Timeframe: First day of study treatment through 28 days following vaccination

Outcome measures

Outcome measures
Measure	MVA.tHIVconsv3 (M3) n=7 Participants Participants in this arm receive one vaccine dose of MVA.tHIVconsv3 (M3) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv4 (M4) n=7 Participants Participants in this arm receive one vaccine dose of MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) n=8 Participants Participants in this arm receive a single combined dose containing each vaccine type MVA.tHIVconsv4 (M3) + MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	Placebo n=4 Participants Participants in this arm receive one saline (placebo) dose given IM at Day 0 Placebo: The appropriate amount of Sodium Chloride for Injection USP, 0.9%
Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE)	43 percentage of participants Interval 10.0 to 81.0	14 percentage of participants Interval 0.0 to 58.0	0 percentage of participants Interval 0.0 to 64.0	0 percentage of participants Interval 0.0 to 60.0

SECONDARY outcome

Timeframe: First day of study treatment through Day 168 (Week 24) following vaccination

The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 will be used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs will be assessments that are considered related to study product as possible, probable, or definite as defined in the protocol.

Outcome measures

Outcome measures
Measure	MVA.tHIVconsv3 (M3) n=7 Participants Participants in this arm receive one vaccine dose of MVA.tHIVconsv3 (M3) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv4 (M4) n=7 Participants Participants in this arm receive one vaccine dose of MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) n=8 Participants Participants in this arm receive a single combined dose containing each vaccine type MVA.tHIVconsv4 (M3) + MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	Placebo n=4 Participants Participants in this arm receive one saline (placebo) dose given IM at Day 0 Placebo: The appropriate amount of Sodium Chloride for Injection USP, 0.9%
Percent of Participants With a Grade 1 or Higher Treatment-Related Adverse Event (AE)	100 percentage of participants Interval 59.0 to 100.0	100 percentage of participants Interval 59.0 to 100.0	100 percentage of participants Interval 63.0 to 100.0	75 percentage of participants Interval 19.0 to 99.0

Adverse Events

MVA.tHIVconsv3 (M3)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

MVA.tHIVconsv4 (M4)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Cynthia Gay, MD, MPH

University of North Carolina at Chapel Hill

Phone: 919-843-2726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MVA.tHIVconsv3 (M3) n=7 participants at risk Participants in this arm receive one vaccine dose of MVA.tHIVconsv3 (M3) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv4 (M4) n=7 participants at risk Participants in this arm receive one vaccine dose of MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	MVA.tHIVconsv3 (M3)+MVA.tHIVconsv4 (M4) n=8 participants at risk Participants in this arm receive a single combined dose containing each vaccine type MVA.tHIVconsv4 (M3) + MVA.tHIVconsv4 (M4) given IM at Day 0 MVA.tHIVconsv3: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1 MVA.tHIVconsv4: viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1	Placebo n=4 participants at risk Participants in this arm receive one saline (placebo) dose given IM at Day 0 Placebo: The appropriate amount of Sodium Chloride for Injection USP, 0.9%
Gastrointestinal disorders Abdominal Pain	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 2/8 • Number of events 2 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Gastrointestinal disorders Diarrhea	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Gastrointestinal disorders Nausea	57.1% 4/7 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	50.0% 4/8 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	12.5% 1/8 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Chills	57.1% 4/7 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	57.1% 4/7 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	37.5% 3/8 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Fatigue	57.1% 4/7 • Number of events 7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	71.4% 5/7 • Number of events 5 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	62.5% 5/8 • Number of events 5 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	50.0% 2/4 • Number of events 2 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Influenza like illness	57.1% 4/7 • Number of events 7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	28.6% 2/7 • Number of events 2 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	50.0% 4/8 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Injection site discoloration	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Injection site erythema	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	12.5% 1/8 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Injection site pain	85.7% 6/7 • Number of events 13 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	85.7% 6/7 • Number of events 12 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	100.0% 8/8 • Number of events 13 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	50.0% 2/4 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Injection site swelling	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	28.6% 2/7 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Injection site warmth	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 2/8 • Number of events 2 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Malaise	71.4% 5/7 • Number of events 9 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	71.4% 5/7 • Number of events 5 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	37.5% 3/8 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	50.0% 2/4 • Number of events 2 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Pyrexia	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Tissue infiltration	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	37.5% 3/8 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Vessel puncture site hemorrhage	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Vessel puncture site pain	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Injury, poisoning and procedural complications Citrate toxicity	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 2/8 • Number of events 2 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Injury, poisoning and procedural complications Post procedural contusion	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Injury, poisoning and procedural complications Post procedural hematoma	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Injury, poisoning and procedural complications Procedural hypertension	85.7% 6/7 • Number of events 12 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	100.0% 7/7 • Number of events 13 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	87.5% 7/8 • Number of events 15 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	100.0% 4/4 • Number of events 5 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	12.5% 1/8 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Investigations Blood HIV RNA increased	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Investigations Blood creatinine increased	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Investigations Blood pressure increased	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	28.6% 2/7 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	12.5% 1/8 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Investigations Body temperature increased	28.6% 2/7 • Number of events 2 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Metabolism and nutrition disorders Decreased appetite	57.1% 4/7 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	37.5% 3/8 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	28.6% 2/7 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	37.5% 3/8 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Musculoskeletal and connective tissue disorders Myalgia	57.1% 4/7 • Number of events 5 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	71.4% 5/7 • Number of events 7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	50.0% 4/8 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Nervous system disorders Dizziness	42.9% 3/7 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Nervous system disorders Headache	85.7% 6/7 • Number of events 9 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	57.1% 4/7 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	62.5% 5/8 • Number of events 5 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	75.0% 3/4 • Number of events 3 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Nervous system disorders Presyncope	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/8 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	57.1% 4/7 • Number of events 4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	14.3% 1/7 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	12.5% 1/8 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	25.0% 1/4 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.
General disorders Injection site induration	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/7 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	12.5% 1/8 • Number of events 1 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.	0.00% 0/4 • From the time of signing informed consent throughout treatment, a total of approximately 24 weeks.