Trial Outcomes & Findings for A Study of JNJ-64281802 for the Prevention of Dengue Infection (NCT NCT05201794)
NCT ID: NCT05201794
Last Updated: 2025-07-31
Results Overview
Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction \[RT-PCR\]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction \[PCR\] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to \[\>=\] 11 relative units per milliliter \[RU/mL\]).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1595 participants
Primary outcome timeframe
Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)
Results posted on
2025-07-31
Participant Flow
Of 1595 enrolled participants (those who signed informed consent form \[ICF\]): 616 were index cases, 979 were household contacts (HHCs) identified from index cases. Of 616, 411 met the eligibility criteria for index case population (those who signed ICF and had a laboratory-confirmed dengue infection) and are reported below. Out of 979 HHCs, 128 were screen failures. Per plan, index cases were not included in any analysis and 851 randomized HHCs were included in the analysis.
HHCs included family members, acquaintances, co-workers, and community contacts, who were asymptomatic at screening (no clinical dengue symptoms). For safety assessments, although dosing stopped at Day 28, safety data through Day 50 were included in double-blind (DB) prophylactic phase due to drug's extended half-life (\~10 days).
Participant milestones
| Measure |
JNJ-64281802: High Dose Regimen
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Index Case Participants
Index case included all enrolled (on Day 1) participants who were with laboratory-confirmed dengue infection and contributed HHC participants. These index case participants were not randomized to receive study intervention.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
283
|
283
|
285
|
411
|
|
Overall Study
Treated
|
282
|
281
|
284
|
0
|
|
Overall Study
Participants Who Entered Into Follow-up Phase
|
69
|
68
|
69
|
0
|
|
Overall Study
COMPLETED
|
247
|
250
|
252
|
411
|
|
Overall Study
NOT COMPLETED
|
36
|
33
|
33
|
0
|
Reasons for withdrawal
| Measure |
JNJ-64281802: High Dose Regimen
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Index Case Participants
Index case included all enrolled (on Day 1) participants who were with laboratory-confirmed dengue infection and contributed HHC participants. These index case participants were not randomized to receive study intervention.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
12
|
14
|
0
|
|
Overall Study
Adverse Event
|
5
|
5
|
4
|
0
|
|
Overall Study
Protocol-Specified Withdrawal Criterion Met
|
5
|
1
|
4
|
0
|
|
Overall Study
Non-Compliance With Study Drug
|
2
|
3
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
3
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
0
|
0
|
|
Overall Study
Non-Compliance With Study Schedule
|
1
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Site Terminated By Sponsor
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
3
|
3
|
3
|
0
|
|
Overall Study
Randomized But Not Treated
|
1
|
2
|
1
|
0
|
Baseline Characteristics
A Study of JNJ-64281802 for the Prevention of Dengue Infection
Baseline characteristics by cohort
| Measure |
JNJ-64281802: High Dose Regimen
n=282 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=281 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=284 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Index Case Participants
n=411 Participants
Index case included all enrolled (on Day 1) participants who were with laboratory-confirmed dengue infection and contributed HHC participants. These index case participants were not randomized to receive study intervention.
|
Total
n=1258 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
Thailand
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Region of Enrollment
Peru
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Age, Continuous
|
34.8 Years
STANDARD_DEVIATION 12.07 • n=5 Participants
|
33.3 Years
STANDARD_DEVIATION 11.67 • n=7 Participants
|
34.7 Years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
28.2 Years
STANDARD_DEVIATION 16.54 • n=4 Participants
|
32.3 Years
STANDARD_DEVIATION 13.81 • n=21 Participants
|
|
Sex/Gender, Customized
Female
|
152 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
664 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
130 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
593 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Undifferentiated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
235 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
312 Participants
n=4 Participants
|
1016 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
159 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
643 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
217 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Region of Enrollment
Colombia
|
132 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
502 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Region of Enrollment
Panama
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Region of Enrollment
Philippines
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)Population: Primary analysis set(PAS): all randomized participants who received at least 1 dose of study intervention, who had no evidence of DENV infection at baseline (based on target not detected \[TND\] results for DENV RNA assay and if available, negative/borderline result for NS1 protein assays) and with at least 1 result for DENV RNA or NS1 protein assay available post baseline up to and including last day of dosing + 1 day. As pre-planned, data collection and analysis was not performed for index case.
Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction \[RT-PCR\]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction \[PCR\] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to \[\>=\] 11 relative units per milliliter \[RU/mL\]).
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=265 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=266 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=265 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline
|
2 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)Population: Complete analysis set: All participants included in PAS or secondary analysis set (SAS) (all randomized participants who received at least 1 dose of study intervention, had evidence of DENV infection \[based on positive results for DENV RNA or NS1 protein assays at baseline\] but without DENV signs and symptoms at baseline). As pre-planned, data collection and analysis was not performed for index case.
Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for \>=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result \>=11 RU/mL).
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=269 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=269 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=270 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline)
|
1 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)Population: PAS included all randomized participants who received at least 1 dose of study intervention, who had no evidence of DENV infection at baseline (based on TND\] results for DENV RNA assay and, if available, a negative/borderline result for NS1 protein assays) and with at least 1 result for DENV RNA or NS1 protein assay available post baseline up to and including the last day of dosing + 1 day. As pre-planned, data collection and analysis was not performed for index case.
Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for \>=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result \>=11 RU/mL).
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=265 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=266 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=265 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: DB prophylactic phase: From start of study treatment (Day 1) up to visit Day 50, considering the long half-life (~10 days) of the study intervention; Follow-up phase: From visit Day 50 up to Day 90Population: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. As pre-planned, data collection and analysis was not performed for index case.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=282 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=281 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=284 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
n=69 Participants
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
n=68 Participants
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
n=69 Participants
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAE
|
169 Participants
|
162 Participants
|
176 Participants
|
13 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAE
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of drug administration (DB prophylactic Day 1) up to Day 50Population: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. Only parameter (SBP: Hypertension) in which at least 1 participant had data was reported. As pre-planned, data collection and analysis was not performed for index case.
Vital signs: pulse and blood pressure (systolic blood pressure\[SBP\]/diastolic blood pressure\[DBP\]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury\[mmHg\]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (\>)150-155, G3(severe):\>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (\<)85, G3(severe):\<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):\>95-100, G3(severe):\>100; Pulse(beats per minutes\[bpm\]):Tachycardia: G1(mild):\>100-115, G2(moderate):\>115-130, G3(severe):\>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):\<50-45, G3(severe):\<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached.
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=255 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=258 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=259 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified rows. Only those parameters in which at least 1 participant had data was reported in this outcome measure. As pre-planned, data collection and analysis was not performed for index case.
ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: \< 45, high: \>=120; PR Interval (milliseconds \[ms\]): low: \<110, high: \>=220; QRS interval (ms): high: \>=120; QTcB and QTcF (ms): Borderline prolonged QT: 450\< QTc \<=480, 480 \<QTc \<=500, QTc \>500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=252 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=254 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=258 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
Heart Rate: Abnormally Low (<45)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
PR Interval, Aggregate: Abnormally High (>=220)
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
PR Interval, Aggregate: Abnormally Low (<110)
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
QTcB Interval, Aggregate: Borderline prolonged QT (450< QTc <=480)
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
QTcF Interval, Aggregate: Borderline prolonged QT (450< QTc <=480)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
QRS Duration, Aggregate: Abnormally High (>=120)
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of drug administration (DB prophylactic Day 1) up to Day 50Population: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified rows. Only those parameters in which at least 1 participant had data was reported in this outcome measure. As pre-planned, data collection and analysis was not performed for index case.
Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=271 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=270 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=278 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Hematology: Hemoglobin, Low: Grade 3
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Hematology: Hemoglobin, Low: Grade 4
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Hematology: Activated partial thromboplastin time (APTT), High: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Hematology: APTT, High: Grade 4
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Hematology: Prothrombin time (PT), High: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Hematology: PT, High: Grade 4
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Hematology: Platelets, Decrease: Grade 3
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hyperglycemia: Grade 3
|
10 Participants
|
17 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hypoglycemia: Grade 3
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hypoglycemia: Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Triglycerides (Fasting), High: Grade 3
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Cholesterol, High: Grade 3
|
22 Participants
|
17 Participants
|
20 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Low density lipoprotein (Fasting), High: Grade 3
|
4 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hypernatremia: Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Creatine Kinase, High: Grade 3
|
2 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Creatine Kinase, High: Grade 4
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Alanine aminotransferase or Serum glutamic pyruvic transaminase (SGPT), High: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Uric Acid, High: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hyperkalemia: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hypokalemia: Grade 3
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Gamma Glutamyl Transferase, High: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Amylase (Pancreatic), High: Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hypophosphatemia: Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Aspartate aminotransferase or Serum glutamic-oxaloacetic transaminase, High: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hyperbilirubinemia: Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hypercalcemia: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Hypocalcemia: Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Chemistry: Lipase, High: Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Urinalysis: Protein, High: Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Urinalysis: Glycosuria: Grade 3
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 50Population: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. As pre-planned, data collection and analysis was not performed for index case.
Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion.
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=248 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=250 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
n=255 Participants
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examinations
|
7 Participants
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90Population: Pharmacokinetic analysis set included all participants who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value after dosing. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure, 'n' (number analyzed) refers to all participants evaluable at specified time points. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
Outcome measures
| Measure |
JNJ-64281802: High Dose Regimen
n=267 Participants
During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
JNJ-64281802: Low Dose Regimen
n=268 Participants
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Placebo
During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Plasma Concentrations of JNJ-64281802
Pre-dose on Day 1
|
1.9 Nanograms per milliliter (ng/mL)
Standard Deviation 31.52
|
4.2 Nanograms per milliliter (ng/mL)
Standard Deviation 69.03
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Post-dose on Day 3
|
4233.5 Nanograms per milliliter (ng/mL)
Standard Deviation 1534.79
|
1777.1 Nanograms per milliliter (ng/mL)
Standard Deviation 732.09
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Post-dose on Day 5
|
2735.0 Nanograms per milliliter (ng/mL)
Standard Deviation 1370.95
|
1037.1 Nanograms per milliliter (ng/mL)
Standard Deviation 505.93
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Post-dose on Day 9
|
2583.1 Nanograms per milliliter (ng/mL)
Standard Deviation 1311.77
|
909.1 Nanograms per milliliter (ng/mL)
Standard Deviation 469.41
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Post-dose on Day 13
|
2657.4 Nanograms per milliliter (ng/mL)
Standard Deviation 1380.73
|
865.8 Nanograms per milliliter (ng/mL)
Standard Deviation 439.79
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Post-dose on Day 21
|
2649.4 Nanograms per milliliter (ng/mL)
Standard Deviation 1606.28
|
846.9 Nanograms per milliliter (ng/mL)
Standard Deviation 495.83
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Post-dose on Day 28
|
2614.1 Nanograms per milliliter (ng/mL)
Standard Deviation 1653.06
|
816.1 Nanograms per milliliter (ng/mL)
Standard Deviation 535.34
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Day 40
|
1194.8 Nanograms per milliliter (ng/mL)
Standard Deviation 858.11
|
325.4 Nanograms per milliliter (ng/mL)
Standard Deviation 238.77
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Day 50
|
640.2 Nanograms per milliliter (ng/mL)
Standard Deviation 543.84
|
165.4 Nanograms per milliliter (ng/mL)
Standard Deviation 143.87
|
—
|
—
|
—
|
—
|
|
Plasma Concentrations of JNJ-64281802
Day 90
|
57.3 Nanograms per milliliter (ng/mL)
Standard Deviation 82.76
|
12.0 Nanograms per milliliter (ng/mL)
Standard Deviation 18.82
|
—
|
—
|
—
|
—
|
Adverse Events
DB Prophylactic Phase: JNJ-64281802: High Dose Regimen
Serious events: 3 serious events
Other events: 107 other events
Deaths: 1 deaths
DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen
Serious events: 0 serious events
Other events: 106 other events
Deaths: 0 deaths
DB Prophylactic Phase: Placebo
Serious events: 1 serious events
Other events: 109 other events
Deaths: 0 deaths
Follow-up Phase: JNJ-64281802: High Dose Regimen
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Follow-up Phase: JNJ-64281802: Low Dose Regimen
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Follow-up Phase: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Prophylactic Phase: JNJ-64281802: High Dose Regimen
n=282 participants at risk
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\~10 days) of the study intervention.
|
DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen
n=281 participants at risk
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\~10 days) of the study intervention.
|
DB Prophylactic Phase: Placebo
n=284 participants at risk
During the DB prophylactic dosing phase, HHC participants received placebo (matching JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\~10 days) of the study intervention.
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
n=69 participants at risk
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
n=68 participants at risk
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
n=69 participants at risk
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.35%
1/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.35%
1/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.35%
1/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.35%
1/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Injury, poisoning and procedural complications
Crush Injury
|
0.35%
1/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Vascular disorders
Hypertensive Crisis
|
0.35%
1/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
Other adverse events
| Measure |
DB Prophylactic Phase: JNJ-64281802: High Dose Regimen
n=282 participants at risk
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\~10 days) of the study intervention.
|
DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen
n=281 participants at risk
During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\~10 days) of the study intervention.
|
DB Prophylactic Phase: Placebo
n=284 participants at risk
During the DB prophylactic dosing phase, HHC participants received placebo (matching JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\~10 days) of the study intervention.
|
Follow-up Phase: JNJ-64281802: High Dose Regimen
n=69 participants at risk
After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: JNJ-64281802: Low Dose Regimen
n=68 participants at risk
After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
Follow-up Phase: Placebo
n=69 participants at risk
After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.8%
8/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
2.5%
7/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
2.1%
6/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
2.9%
2/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.9%
4/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
2.9%
2/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.7%
16/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
4.6%
13/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
7.0%
20/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
35/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
8.2%
23/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
8.1%
23/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.5%
1/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Gastrointestinal disorders
Nausea
|
6.4%
18/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
7.5%
21/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
8.5%
24/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
8/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
2.8%
8/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.3%
15/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
General disorders
Fatigue
|
5.7%
16/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
8.9%
25/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
9.2%
26/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.5%
1/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
General disorders
Pyrexia
|
7.8%
22/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
8.9%
25/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
13.7%
39/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.8%
4/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
4.4%
3/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
7.2%
5/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.1%
6/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
3.2%
9/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
7.0%
20/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
2.9%
2/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.7%
19/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.3%
15/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
7.0%
20/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
17/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
6.0%
17/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
8.1%
23/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
4.3%
3/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
4.4%
3/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.8%
4/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
13/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.3%
15/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
8.8%
25/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
1/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.5%
1/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Nervous system disorders
Headache
|
19.1%
54/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
21.7%
61/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
23.6%
67/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.8%
4/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
7.4%
5/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.8%
4/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
3/282 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
0.00%
0/281 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
1.4%
4/284 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
4.3%
3/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
5.9%
4/68 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
4.3%
3/69 • All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)
All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\~10 days).
|
Additional Information
Senior Medical Leader
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER