Trial Outcomes & Findings for A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002) (NCT NCT01513239)
NCT ID: NCT01513239
Last Updated: 2018-09-05
Results Overview
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1203 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-09-05
Participant Flow
Male and female participants 18 years of age or older, diagnosed with Clostridium difficile infection (CDI) and receiving Standard of Care (SOC) therapy were recruited for this trial.
Participant milestones
| Measure |
MK-3415A + SOC
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
MK-3415A + SOC 9-ME
9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
|
MK-6072 + SOC 9-ME
9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
|
Placebo + SOC 9-ME
9-ME for participants treated with Placebo
|
|---|---|---|---|---|---|---|
|
Period 1: Main Phase
STARTED
|
397
|
407
|
399
|
0
|
0
|
0
|
|
Period 1: Main Phase
Treated
|
391
|
396
|
381
|
0
|
0
|
0
|
|
Period 1: Main Phase
All Participants as Treated
|
390
|
396
|
381
|
0
|
0
|
0
|
|
Period 1: Main Phase
COMPLETED
|
322
|
337
|
311
|
0
|
0
|
0
|
|
Period 1: Main Phase
NOT COMPLETED
|
75
|
70
|
88
|
0
|
0
|
0
|
|
Period 2: 9 Month Extension Phase
STARTED
|
0
|
0
|
0
|
112
|
100
|
83
|
|
Period 2: 9 Month Extension Phase
COMPLETED
|
0
|
0
|
0
|
102
|
90
|
78
|
|
Period 2: 9 Month Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
10
|
10
|
5
|
Reasons for withdrawal
| Measure |
MK-3415A + SOC
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
MK-3415A + SOC 9-ME
9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
|
MK-6072 + SOC 9-ME
9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
|
Placebo + SOC 9-ME
9-ME for participants treated with Placebo
|
|---|---|---|---|---|---|---|
|
Period 1: Main Phase
Adverse Event
|
1
|
1
|
2
|
0
|
0
|
0
|
|
Period 1: Main Phase
Death
|
29
|
22
|
32
|
0
|
0
|
0
|
|
Period 1: Main Phase
Lost to Follow-up
|
11
|
10
|
6
|
0
|
0
|
0
|
|
Period 1: Main Phase
Physician Decision
|
4
|
4
|
4
|
0
|
0
|
0
|
|
Period 1: Main Phase
Protocol Violation
|
2
|
2
|
2
|
0
|
0
|
0
|
|
Period 1: Main Phase
Technical Problems
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Period 1: Main Phase
Withdrawal by Subject
|
27
|
29
|
42
|
0
|
0
|
0
|
|
Period 2: 9 Month Extension Phase
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
3
|
2
|
|
Period 2: 9 Month Extension Phase
Death
|
0
|
0
|
0
|
2
|
5
|
2
|
|
Period 2: 9 Month Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Period 2: 9 Month Extension Phase
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 2: 9 Month Extension Phase
Technical Problems
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
Baseline characteristics by cohort
| Measure |
MK-3415A + SOC
n=397 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=407 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=399 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
Total
n=1203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
62.6 Years
STANDARD_DEVIATION 17.5 • n=7 Participants
|
64.3 Years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 17.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
675 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
528 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The (Full Analysis Set) FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.
Outcome measures
| Measure |
MK-3415A + SOC
n=390 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=395 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=378 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence
|
14.9 Percentage of participants
|
15.7 Percentage of participants
|
25.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK- 3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.
Outcome measures
| Measure |
MK-3415A + SOC
n=390 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=396 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=381 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment
|
57.4 Percentage of participants
|
58.1 Percentage of participants
|
60.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.
Outcome measures
| Measure |
MK-3415A + SOC
n=390 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=396 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=381 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment
|
6.7 Percentage of participants
|
6.8 Percentage of participants
|
6.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.
A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.
Outcome measures
| Measure |
MK-3415A + SOC
n=390 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=396 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=381 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.
Outcome measures
| Measure |
MK-3415A + SOC
n=390 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=396 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=381 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 hoursPopulation: APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.
Outcome measures
| Measure |
MK-3415A + SOC
n=390 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=396 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=381 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion
|
7.2 Percentage of participants
|
8.8 Percentage of participants
|
7.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.
Global cure is defined as the clinical cure of the initial CDI episode with no CDI recurrence through Week 12. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.
Outcome measures
| Measure |
MK-3415A + SOC
n=390 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=395 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=378 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With Global Cure
|
57.4 Percentage of participants
|
66.8 Percentage of participants
|
52.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated participants who achieved a clinical cure of the initial CDI episode.
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.
Outcome measures
| Measure |
MK-3415A + SOC
n=282 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=326 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=294 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode
|
20.6 Percentage of participants
|
19.0 Percentage of participants
|
33.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated participants with a history of CDI in the past 6 months.
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.
Outcome measures
| Measure |
MK-3415A + SOC
n=104 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=113 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=110 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment
|
20.2 Percentage of participants
|
23.9 Percentage of participants
|
42.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated participants with the 027 ribotype
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen. The 027 ribotype is a more virulent, epidemic strain responsible for several outbreaks of disease associated with an increased risk of severity and mortality.
Outcome measures
| Measure |
MK-3415A + SOC
n=39 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=43 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=64 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype
|
12.8 Percentage of participants
|
20.9 Percentage of participants
|
32.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated participants with an epidemic strain
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen. An epidemic strain includes ribotypes 027, 014, 002, 001, 106 or 020.
Outcome measures
| Measure |
MK-3415A + SOC
n=116 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=102 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=127 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain
|
14.7 Percentage of participants
|
18.6 Percentage of participants
|
29.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated participants with clinically severe CDI
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen. Participants with clinically severe CDI have a Zar Score greater than or equal to 2 points based on the presence of 1 or more of the following: 1) age \>60 years old (1 point); 2) body temperature \>38.3°C (\>100°F) (1 point); 3) albumin level ˂2.5 mg/dl (1 point); 4) peripheral white blood cell count \>15,000 cells/mm\^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).
Outcome measures
| Measure |
MK-3415A + SOC
n=80 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=55 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=65 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI
|
11.3 Percentage of participants
|
10.9 Percentage of participants
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated participants 65 years and older.
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.
Outcome measures
| Measure |
MK-3415A + SOC
n=241 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=205 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=206 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence in Those 65 Years and Older
|
17.4 Percentage of participants
|
15.6 Percentage of participants
|
29.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Treated participants with compromised immunity
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen. Compromised immunity is an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.
Outcome measures
| Measure |
MK-3415A + SOC
n=85 Participants
Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
|
MK-6072 + SOC
n=91 Participants
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=61 Participants
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
|---|---|---|---|
|
Percentage of Participants With CDI Recurrence in Those With Compromised Immunity
|
16.5 Percentage of participants
|
12.1 Percentage of participants
|
26.2 Percentage of participants
|
Adverse Events
MK-3415A + SOC
Serious events: 118 serious events
Other events: 37 other events
Deaths: 31 deaths
MK-6072 + SOC
Serious events: 111 serious events
Other events: 44 other events
Deaths: 25 deaths
Placebo + SOC
Serious events: 129 serious events
Other events: 37 other events
Deaths: 33 deaths
MK-3415 + SOC
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
MK-3415A + SOC 9-ME
Serious events: 6 serious events
Other events: 0 other events
Deaths: 2 deaths
MK-6072 + SOC 9-ME
Serious events: 7 serious events
Other events: 0 other events
Deaths: 5 deaths
Placebo + SOC 9-ME
Serious events: 3 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
MK-3415A + SOC
n=390 participants at risk
Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
|
MK-6072 + SOC
n=396 participants at risk
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=381 participants at risk
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
MK-3415 + SOC
n=1 participants at risk
Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI
|
MK-3415A + SOC 9-ME
n=112 participants at risk
9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
|
MK-6072 + SOC 9-ME
n=100 participants at risk
9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
|
Placebo + SOC 9-ME
n=83 participants at risk
9-ME for participants treated with Placebo
|
|---|---|---|---|---|---|---|---|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Fatigue
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
General physical health deterioration
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Generalised oedema
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Impaired healing
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Influenza like illness
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Multi-organ failure
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Non-cardiac chest pain
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Oedema peripheral
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Pelvic mass
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Pyrexia
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Suprapubic pain
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Hepatobiliary disorders
Cholangitis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.76%
3/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Arrhythmia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.79%
3/381 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Cardiac failure
|
1.3%
5/390 • Number of events 5 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.76%
3/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Cardiac failure acute
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.76%
3/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
5/390 • Number of events 5 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.3%
5/396 • Number of events 5 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Prinzmetal angina
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Eye disorders
Blindness unilateral
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
2/390 • Number of events 5 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
4/396 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
4/390 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.8%
7/396 • Number of events 7 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.6%
6/381 • Number of events 6 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Dysphagia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
4/396 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Haematochezia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Ileus
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Asthenia
|
0.77%
3/390 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Chest pain
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Death
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Device breakage
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Device malfunction
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
General disorders
Disuse syndrome
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Immune system disorders
Anaphylactic reaction
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Bacteraemia
|
0.77%
3/390 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Cellulitis
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Clostridium difficile infection
|
3.3%
13/390 • Number of events 13 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
3.5%
14/396 • Number of events 15 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
7.3%
28/381 • Number of events 34 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.2%
1/83 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Device related infection
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Diabetic foot infection
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Erysipelas
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Fungaemia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Gangrene
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
HIV infection
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Influenza
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Lung abscess
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Necrotising fasciitis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Pneumonia
|
2.3%
9/390 • Number of events 9 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.3%
5/396 • Number of events 5 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
2.4%
9/381 • Number of events 9 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.2%
1/83 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Sepsis
|
0.77%
3/390 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.5%
6/396 • Number of events 7 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
3.4%
13/381 • Number of events 14 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Septic shock
|
0.77%
3/390 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.6%
6/381 • Number of events 6 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
7/390 • Number of events 7 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
2.3%
9/396 • Number of events 11 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
4/381 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Urosepsis
|
1.0%
4/390 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Viraemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Wound infection
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
Alanine aminotransferase increased
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
Aspartate aminotransferase increased
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
Blood lactic acid increased
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
Escherichia test positive
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medulloblastoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Cerebral infarction
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.2%
1/83 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Dementia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Loss of consciousness
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Neuralgia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Presyncope
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Seizure
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Senile dementia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
—
0/0 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
—
0/0 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
—
0/0 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Spinal cord compression
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Status epilepticus
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Syncope
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.51%
2/390 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Psychiatric disorders
Agitation
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Psychiatric disorders
Mental status changes
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
4/381 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
100.0%
1/1 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
4/381 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Renal and urinary disorders
Nephritic syndrome
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.77%
3/390 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.79%
3/381 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.77%
3/390 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.3%
5/396 • Number of events 5 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.79%
3/381 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
2.0%
2/100 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
4/390 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.76%
3/396 • Number of events 4 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Hypertension
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Hypertensive crisis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Hypotension
|
0.51%
2/390 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Phlebitis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Shock
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Vascular disorders
Thrombophlebitis
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
100.0%
1/1 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.89%
1/112 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/381 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
1.0%
1/100 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
Other adverse events
| Measure |
MK-3415A + SOC
n=390 participants at risk
Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
|
MK-6072 + SOC
n=396 participants at risk
Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
|
Placebo + SOC
n=381 participants at risk
Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
|
MK-3415 + SOC
n=1 participants at risk
Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI
|
MK-3415A + SOC 9-ME
n=112 participants at risk
9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC
|
MK-6072 + SOC 9-ME
n=100 participants at risk
9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC
|
Placebo + SOC 9-ME
n=83 participants at risk
9-ME for participants treated with Placebo
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
17/390 • Number of events 19 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
4.3%
17/396 • Number of events 18 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
5.5%
21/381 • Number of events 23 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
17/390 • Number of events 17 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
5.8%
23/396 • Number of events 23 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
3.1%
12/381 • Number of events 12 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Infections and infestations
Clostridium difficile infection
|
1.0%
4/390 • Number of events 5 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.76%
3/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.52%
2/381 • Number of events 2 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
100.0%
1/1 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
Lymphocyte count decreased
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/396 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
100.0%
1/1 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
Neutrophil count increased
|
0.26%
1/390 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.51%
2/396 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.79%
3/381 • Number of events 3 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
100.0%
1/1 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
|
Investigations
White blood cell count increased
|
0.00%
0/390 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.25%
1/396 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.26%
1/381 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
100.0%
1/1 • Number of events 1 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/112 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/100 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
0.00%
0/83 • Non-serious adverse events up to Day 28; serious adverse events up to Day 90
Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study). 9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER