Trial Outcomes & Findings for Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036) (NCT NCT04633226)
NCT ID: NCT04633226
Last Updated: 2024-09-24
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs consist of erythema, induration, pain, and swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
Up to 7 days after any vaccination, up to a total of ~ 13 months
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
V114
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
Vaccination 1 (~2 Months of Age)
|
57
|
|
Overall Study
Vaccination 2 (~4 Months of Age)
|
56
|
|
Overall Study
Vaccination 3 (~6 Months of Age)
|
55
|
|
Overall Study
Vaccination 4 (~12 to 15 Months of Age)
|
50
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
V114
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Overall Study
Withdrawal by parent/guardian
|
4
|
|
Overall Study
Randomized by mistake without study treatment
|
1
|
Baseline Characteristics
Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
Baseline characteristics by cohort
| Measure |
V114
n=58 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Age, Continuous
|
8.7 weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
58 Participants
n=5 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=5 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after any vaccination, up to a total of ~ 13 monthsPopulation: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs consist of erythema, induration, pain, and swelling.
Outcome measures
| Measure |
V114
n=57 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
Injection site erythema
|
54.4 Percentage of Participants
|
|
Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
Injection site induration
|
57.9 Percentage of Participants
|
|
Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
Injection site pain
|
50.9 Percentage of Participants
|
|
Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
Injection site swelling
|
59.6 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after any vaccination, up to a total of ~ 13 monthsPopulation: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs consist of decreased appetite, irritability, somnolence, and urticaria.
Outcome measures
| Measure |
V114
n=57 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Percentage of Participants With ≥1 Solicited Systemic Adverse Events
Decreased appetite
|
71.9 Percentage of Participants
|
|
Percentage of Participants With ≥1 Solicited Systemic Adverse Events
Irritability
|
89.5 Percentage of Participants
|
|
Percentage of Participants With ≥1 Solicited Systemic Adverse Events
Somnolence
|
82.5 Percentage of Participants
|
|
Percentage of Participants With ≥1 Solicited Systemic Adverse Events
Urticaria
|
8.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to approximately 14.5 monthsPopulation: All randomized participants who received at least 1 dose of study vaccination were analyzed.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following any dose of V114 was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Outcome measures
| Measure |
V114
n=57 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 6.3
|
PRIMARY outcome
Timeframe: Up to approximately 13 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study vaccination.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinued study treatment due to an AE is reported.
Outcome measures
| Measure |
V114
n=57 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 6.3
|
PRIMARY outcome
Timeframe: 30 days after vaccination 3 (Up to a total of ~5 months)Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. Deviations include randomized but not vaccinated, prior pneumococcal vaccine, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, or missing serology results.
The percentage of participants with immunoglobulin G (IgG) threshold values of ≥0.35 µg/mL for the 15 serotypes contained in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 30 days postdose 3 is reported. The multiplex, pneumococcal electrochemiluminescence (PnECL) v2.0 assay was used to quantify IgG serotype-specific antibodies.
Outcome measures
| Measure |
V114
n=47 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 1
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 3
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 4
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 5
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 6A
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 6B
|
95.7 Percentage of Participants
Interval 85.5 to 99.5
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 7F
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 9V
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 14
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 18C
|
97.9 Percentage of Participants
Interval 88.7 to 99.9
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 19A
|
97.9 Percentage of Participants
Interval 88.7 to 99.9
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 19F
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 22F
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 23F
|
100.0 Percentage of Participants
Interval 92.5 to 100.0
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Serotype 33F
|
97.9 Percentage of Participants
Interval 88.7 to 99.9
|
PRIMARY outcome
Timeframe: 30 days after vaccination 3 (Up to a total of ~5 months)Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. Deviations include randomized but not vaccinated, prior pneumococcal vaccine, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, or missing serology results.
The anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG geometric mean concentrations (GMCs) at 30 days postdose 3 for each serotype-specific were reported. The multiplex, electrochemiluminescence (ECL)-based PnECL v2.0 assay was used to quantify IgG serotype-specific antibodies.
Outcome measures
| Measure |
V114
n=47 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 1
|
1.69 μg/mL
Interval 1.46 to 1.94
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 3
|
1.70 μg/mL
Interval 1.41 to 2.06
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 4
|
1.87 μg/mL
Interval 1.49 to 2.34
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 5
|
2.14 μg/mL
Interval 1.74 to 2.63
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 6A
|
2.16 μg/mL
Interval 1.74 to 2.67
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 6B
|
2.53 μg/mL
Interval 1.93 to 3.32
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 7F
|
2.80 μg/mL
Interval 2.35 to 3.32
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 9V
|
2.01 μg/mL
Interval 1.63 to 2.47
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 14
|
7.47 μg/mL
Interval 5.98 to 9.32
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 18C
|
1.90 μg/mL
Interval 1.47 to 2.46
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 19A
|
2.20 μg/mL
Interval 1.76 to 2.76
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 19F
|
3.04 μg/mL
Interval 2.55 to 3.63
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 22F
|
5.97 μg/mL
Interval 4.83 to 7.37
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 23F
|
1.71 μg/mL
Interval 1.37 to 2.15
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Serotype 33F
|
2.41 μg/mL
Interval 1.84 to 3.15
|
SECONDARY outcome
Timeframe: 30 days after vaccination 4 (Up to a total of ~14 months)Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. Deviations include vaccination out of window, blood draw out of window, or prohibited concomitant medication or vaccine.
The anti-PnPs serotype-specific IgG GMCs at 30 days postdose 4 for each serotype-specific were reported. The multiplex, ECL-based PnECL v2.0 assay was used.
Outcome measures
| Measure |
V114
n=49 Participants
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 1
|
2.24 μg/mL
Interval 1.77 to 2.83
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 3
|
1.32 μg/mL
Interval 1.07 to 1.62
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 4
|
1.86 μg/mL
Interval 1.39 to 2.49
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 5
|
3.27 μg/mL
Interval 2.57 to 4.17
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 6A
|
5.77 μg/mL
Interval 4.38 to 7.6
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 6B
|
6.80 μg/mL
Interval 5.28 to 8.76
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 7F
|
5.17 μg/mL
Interval 3.92 to 6.81
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 9V
|
3.27 μg/mL
Interval 2.5 to 4.28
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 14
|
9.04 μg/mL
Interval 7.22 to 11.31
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 18C
|
3.81 μg/mL
Interval 2.97 to 4.88
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 19A
|
4.91 μg/mL
Interval 4.03 to 5.97
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 19F
|
5.41 μg/mL
Interval 4.4 to 6.65
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 22F
|
9.20 μg/mL
Interval 7.19 to 11.79
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 23F
|
2.82 μg/mL
Interval 2.14 to 3.73
|
|
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Serotype 33F
|
6.21 μg/mL
Interval 5.05 to 7.63
|
Adverse Events
V114
Serious events: 4 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=57 participants at risk
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
General disorders
Pyrexia
|
1.8%
1/57 • Number of events 1 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Asymptomatic COVID-19
|
1.8%
1/57 • Number of events 1 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
1.8%
1/57 • Number of events 1 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/57 • Number of events 1 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.8%
1/57 • Number of events 1 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
V114
n=57 participants at risk
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
3/57 • Number of events 5 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site erythema
|
54.4%
31/57 • Number of events 64 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site induration
|
57.9%
33/57 • Number of events 70 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site pain
|
50.9%
29/57 • Number of events 73 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site swelling
|
59.6%
34/57 • Number of events 72 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
General disorders
Injection site urticaria
|
15.8%
9/57 • Number of events 13 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
33.3%
19/57 • Number of events 27 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
5/57 • Number of events 7 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
71.9%
41/57 • Number of events 65 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
82.5%
47/57 • Number of events 108 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Irritability
|
89.5%
51/57 • Number of events 138 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
3/57 • Number of events 3 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.8%
5/57 • Number of events 7 • Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER