Trial Outcomes & Findings for A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (NCT NCT04439539)
NCT ID: NCT04439539
Last Updated: 2025-06-24
Results Overview
Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at the end of consolidation phase and without restarting NA treatment) were reported. Seroclearance HBsAg was defined as a (quantitative) HBsAg level \<lower limit of quantification (LLOQ; \<0.05 international units per milliliter \[IU/mL\]).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
At follow-up (FU) phase Week 24
Results posted on
2025-06-24
Participant Flow
Per protocol amendment (PA) 6, all participants stopped JNJ-56136379 (JNJ-6379) treatment and switched to single-arm study design: JNJ-73763989 (JNJ-3989) plus nucleos(t)ide analog (NA; tenofovir disoproxil/tenofovir Alafenamide) plus pegylated interferon alpha-2a (PegIFN-alpha-2a). The Study had of 3 phases: induction phase (IP), consolidation phase (CP) and follow-up (FU) phase.
Response-guided treatment (RGT): Hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per millilitre (IU/mL). Post PA 5, RGT criterion was removed. Nucleos(t)ide (NA) treatment completion criteria: HBsAg \<10 IU/mL, HB envelop antigen (HBeAg)-negative, and HB virus deoxyribonucleic acid (HBV DNA) \<lower limit of quantification (LLOQ) and alanine aminotransferase (ALT) \<3\*upper limit of normal (ULN).
Participant milestones
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
|---|---|---|---|
|
IP:Day 1-Week 36(Post-PA5)/52(Prior-PA5)
STARTED
|
27
|
8
|
19
|
|
IP:Day 1-Week 36(Post-PA5)/52(Prior-PA5)
COMPLETED
|
26
|
8
|
17
|
|
IP:Day 1-Week 36(Post-PA5)/52(Prior-PA5)
NOT COMPLETED
|
1
|
0
|
2
|
|
Consolidation Phase (CP):CP Week 1 to 12
STARTED
|
25
|
7
|
17
|
|
Consolidation Phase (CP):CP Week 1 to 12
COMPLETED
|
25
|
7
|
17
|
|
Consolidation Phase (CP):CP Week 1 to 12
NOT COMPLETED
|
0
|
0
|
0
|
|
Follow-up (FU) Phase: FU Week 1 to 48
STARTED
|
26
|
8
|
17
|
|
Follow-up (FU) Phase: FU Week 1 to 48
COMPLETED
|
26
|
6
|
17
|
|
Follow-up (FU) Phase: FU Week 1 to 48
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
|---|---|---|---|
|
IP:Day 1-Week 36(Post-PA5)/52(Prior-PA5)
Withdrawal by Subject
|
1
|
0
|
2
|
|
Follow-up (FU) Phase: FU Week 1 to 48
Other
|
0
|
1
|
0
|
|
Follow-up (FU) Phase: FU Week 1 to 48
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
Baseline characteristics by cohort
| Measure |
Cohort 1: JNJ-3989 200 mg + JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP) received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN). was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 9.95 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 10.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
CANADA
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
FRANCE
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
GERMANY
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
JAPAN
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
SPAIN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
TAIWAN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
TURKEY
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At follow-up (FU) phase Week 24Population: Per protocol analysis set: all randomized/enrolled participants who received at least 1 dose of CP study intervention and did not had any of the selected major protocol deviations that might affect the assessment of efficacy in terms of the primary endpoint at 24 weeks after stopping all study interventions of the CP.
Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at the end of consolidation phase and without restarting NA treatment) were reported. Seroclearance HBsAg was defined as a (quantitative) HBsAg level \<lower limit of quantification (LLOQ; \<0.05 international units per milliliter \[IU/mL\]).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
22 Participants
|
8 Participants
|
15 Participants
|
22 Participants
|
7 Participants
|
13 Participants
|
17 Participants
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Number of participants with TESAEs were reported. was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here, "n"(number analyzed) signifies number of participants analyzed at specified categories.
Clinical laboratory test parameters were Hematology: absolute lymphocyte count, absolute neutrophil count (ANC), hemoglobin, Neutrophils Band Form, Neutrophils segmented, white blood cells (WBC) decreased, ; Chemistry: alanine aminotransferase (ALT) \& serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT), cholesterol (fasting), creatinine Kinase, creatinine, GFR from Creatinine Adjusted for BSA, GFR from Cystatin C Adjusted for BSA, low-density lipoprotein (LDL), triglycerides (fasting); Urinalysis: glycosuria. DAIDS toxicity grades: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). Number of participants with treatment-emergent DAIDS toxicity Grade 3 or 4 were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Hematology: Absolute Lymphocyte Count: Low: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Hematology: Neutrophils Segmented: Low: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Hematology: WBC Decreased: Low: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Hematology: Absolute Neutrophil Count: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Hematology: Hemoglobin: Low: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Hematology: Neutrophils Band Form: Low: Grade 4
|
—
|
—
|
—
|
3 Participants
|
—
|
—
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: ALT or SGPT: High: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: AST or SGOT: High: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: Cholesterol (Fasting): High: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: Creatinine Kinase : High: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: Creatinine Kinase : High: Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: GFR from Cr Adjusted for BSA, Low: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: GFR from Cy C Adjusted for BSA, Low: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: LDL (Fasting): High: Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Chemistry: Triglycerides (Fasting): High: Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests
Urinalysis: Glycosuria: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Safety analysis set included all participants who received at least one dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Number of participants with worst treatment-emergent abnormality in ECG were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. ECG parameters included heart rate (HR; abnormally low, HR \<45 beats per minute (bpm) and (abnormally high HR\>=120 bpm; PR interval abnormally high \>220 milliseconds (ms): QRS interval abnormally high \>=120 ms; QT corrected (Fridericia QTcF) categories; borderline prolonged QTc interval \<450 to \<=480 ms), prolonged QTc interval \<480 to \<=500 ms) and pathologically prolonged QTc interval \>500 ms).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
Number of participants with worst treatment-emergent abnormalities in vital signs were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. Abnormalities in vital signs included abnormal pulse rate (PR); abnormally low, \<=45 bpm and abnormally high \>=120 bpm; diastolic blood pressure (DBP) abnormally low \<=50 mmHg, systolic blood pressure (SBP) abnormally low \<=90 mmHg. Additionally, abnormal low SBP and DBP were \<=50 mmHg and \<+90 mmHg. Only those categories in which at least one participant had data were reported.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
DBP: High:
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
SBP: Low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
SBP: High
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
Pulse rate: High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
Number of participants with clinically important treatment-emergent abnormalities in physical examination were reported.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Important Abnormalities in Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At IP Week 36 and EOI; anytime up to IP Week 52 for Cohort 1; up to IP Week 36 for Cohort 2Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here, "n"(number analyzed) signifies participants who were evaluable at specified timepoints. Data for this outcome measure were planned to be collected and analyzed for IP only.
Percentage of participants who reached HBsAg \<10 IU/mL at the end induction phase were reported.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)
IP Week 36
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
10 percentage of participants
Interval 1.0 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)
End of Induction phase
|
15.4 percentage of participants
Interval 2.0 to 16.0
|
37.5 percentage of participants
|
10.5 percentage of participants
Interval 1.0 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 of IP) up to Follow-up phase Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.
Time to achieve first occurrence of HBsAg \<10 IU/mL were reported. Time to HBsAg \<10 IU/mL was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg \<10 IU/mL. Kaplan-Meier method was used for the estimation.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve First Occurrence of HBsAg <10 IU/mL
|
48.1 weeks
NA indicates that upper limit and lower limit of CI was not estimable due to insufficient number of participants with events.
|
84.3 weeks
Interval 2.1 to
NA indicates that upper limit of 90% CI was not estimable due to insufficient number of participants with events.
|
48.3 weeks
Interval 36.1 to
NA indicates that upper limit of 90% CI was not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At CP Week 12 (for Cohort 1 and 2)Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants meeting the protocol-defined NA treatment completion criteria at end of consolidation were reported. NA treatment completion criteria at CP Week 12 was defined as HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, (that is, LLOQ); alanine aminotransferase(ALT) \<3\*ULN.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=25 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.9 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Percentage of participants with HBsAg seroclearance 48 weeks after stopping all study interventions at the consolidation phase and without restarting NA treatment during follow up phase were reported. HBsAg seroclearance was defined as (quantitative) HBsAg \< LLOQ (HBsAg 0.05 IU/mL).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
|
11.5 percentage of participants
Interval 1.0 to 12.0
|
16.7 percentage of participants
Interval 1.0 to 17.0
|
11.8 percentage of participants
Interval 1.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Percentage of participants with HBV DNA \<LLOQ (\<20 IU/mL) 48 weeks after stopping all study interventions of the consolidation phase and without restarting NA treatment during follow up phase were reported.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=1 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Number of participants with off-treatment virologic HBV flares were reported. Virologic flare was defined as confirmed HBV DNA \>peak threshold (lowest peak to qualify as virologic flare was HBV DNA \>200 IU/mL) in participants who were off-treatment and had HBV DNA \<LLOQ (\<20 IU/mL) at the last observed time point on all study treatments. The 3 thresholds of virologic flare was 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=1 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Number of Participants With Off-treatment Virologic HBV Flares During Follow up Phase
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Number of participants with off-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=1 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Number of Participants With Off-treatment Biochemical HBV Flares During Follow-up Phase
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.
Number of participants with on-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. On-treatment was defined as the time period during which the participant received any of the study drugs.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: FU phase: FU Week 1 up to FU Week 48(up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Clinical flares occurred either when a virologic flare (confirmed HBV DNA \>peak threshold) \& biochemical flare (ALT and/or AST \>=3\*ULN \& \>=3\*nadir \[lowest value observed during off-treatment period up to time point of meeting the flare criteria\]) overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. The HBV DNA thresholds were: 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that criteria was fulfilled at 2 or more consecutive time points or at last observed time point. Off-treatment was defined as time period after stopping all study drugs (including NA). The start date of a clinical flare was minimum start date of virologic flare and biochemical flare.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=1 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. Here, N=0 signifies that data were not collected and analyzed for participants who stopped NA at the end of treatment.
Percentage of participants who required NA re-treatment during follow-up phase were reported. A responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=1 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with sustained (reduction) HBsAg response (per Definition 1) were reported. Sustained HBsAg response (definition 1) was defined as: For participants with FU Week 48 data: participants who had a \>1 log10 decline from baseline in HBsAg and HBsAg \<000 IU/mL at FU Week 48. For participants without FU Week 48 data: participants who had a HBsAg decline from baseline of \>2 log10 at FU Week 24 or \>1.5 log10 at FU Week 36 (most recent value used) and had HBsAg \<1000 IU/mL at the last available timepoint.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
FU Phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48
|
53.85 percentage of participants
Interval 1.0 to 56.0
|
57.1 percentage of participants
Interval 1.0 to 58.0
|
70.6 percentage of participants
Interval 1.0 to 80.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with sustained (reduction) HBsAg response (per Definition 2) were reported. Sustained HBsAg response (per Definition 2) was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was \<0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was \<0.2.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48
|
65.4 percentage of participants
Interval 1.0 to 67.0
|
42.9 percentage of participants
Interval 1.0 to 50.0
|
70.6 percentage of participants
Interval 1.0 to 71.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with sustained (reduction) HBsAg response (per definition 3) were reported. Sustained HBsAg response (per Definition 3) was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was \<0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was \<0.2 and had an HBsAg \<1000 IU/mL at the last available timepoint.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48
|
42.3 percentage of participants
Interval 1.0 to 43.0
|
28.6 percentage of participants
Interval 1.0 to 30.0
|
52.9 percentage of participants
Interval 1.0 to 53.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Percentage of participants with sustained (reduction) HBsAg response per Definition 4 were reported. Sustained HBsAg response (per Definition 4) was defined as stable level, decreasing level, and increasing level. Stable level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was within 0.2 log10. Decreasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was less than -0.2 log10. Increasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was more than 0.2 log10.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48
Increased: > +0.2 log10 IU/mL
|
76.9 percentage of participants
Interval 0.0 to 80.0
|
71.4 percentage of participants
Interval 0.0 to 72.0
|
70.6 percentage of participants
Interval 0.0 to 72.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48
Stable: within +/-0.2 log10 IU/mL
|
0 percentage of participants
Interval 0.0 to 0.0
|
14.3 percentage of participants
Interval 0.0 to 15.0
|
11.8 percentage of participants
Interval 0.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48
Decreased: <0.2 log10 IU/mL
|
19.2 percentage of participants
Interval 0.0 to 20.0
|
14.3 percentage of participants
Interval 0.0 to 15.0
|
17.6 percentage of participants
Interval 0.0 to 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48
Missing
|
3.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of Participants with HBsAg Seroclearance were reported. HBsAg seroclearance was defined as (quantitative) HBsAg level \<LLOQ (\<0.05 IU/mL).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=26 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48
|
11.5 percentage of participants
Interval 1.0 to 12.0
|
16.7 percentage of participants
Interval 1.0 to 17.0
|
11.8 percentage of participants
Interval 1.0 to 90.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At FU Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Percentage of participants with HBeAg seroclearance were reported. HBeAg seroclearance was defined as (quantitative) HBeAg levels \<LLOQ (\<0.11 IU/mL).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=25 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=17 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HBeAg Seroclearance at Follow-up Week 48
|
28.0 percentage of participants
Interval 1.0 to 30.0
|
33.3 percentage of participants
Interval 1.0 to 40.0
|
17.6 percentage of participants
Interval 1.0 to 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: IP Week 24; CP: Week 12, FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies participants evaluable at specified timepoints. Also, n=0 signifies that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ \[\<0.05 IU/mL\]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies \[quantitative\] \<LLOQ \[\<5 milli-international units per milliliter (mIU/mL)\] and a post-baseline assessment \>=LLOQ \[\>=5 mIU/mL\]).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=25 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=15 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=24 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=15 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=15 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Seroconversion
IP: Week 24
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroconversion
CP: Week 12
|
—
|
—
|
—
|
8.3 percentage of participants
|
33.3 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Seroconversion
FU phase Week 48
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—
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12.0 percentage of participants
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6.7 percentage of participants
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SECONDARY outcome
Timeframe: CP: Week 12; FU phase: FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analyzed) signifies participants evaluable at specified timepoints. Data were planned to be collected and analyzed for CP and FU phase only. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as \[quantitative\] HBeAg \<LLOQ \[\<0.11 IU/mL\]) together with appearance of anti-HBe antibodies (defined as a baseline anti-HBe antibodies \[qualitative\] with a "negative" result and a post-baseline assessment with "positive" result).
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=21 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
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Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
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Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=11 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
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CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=22 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
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CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=11 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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Percentage of Participants With HBeAg Seroconversion
CP: Week 12
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0 percentage of participants
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16.7 percentage of participants
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9.1 percentage of participants
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Percentage of Participants With HBeAg Seroconversion
FU phase: week 48
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—
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—
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—
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18.2 percentage of participants
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20.0 percentage of participants
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27.3 percentage of participants
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—
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—
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SECONDARY outcome
Timeframe: Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Change from baseline over time in HBsAg levels at specified timepoints were reported
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=25 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
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Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
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Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=15 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
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CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
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CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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Change From Baseline Over Time in HBsAg Levels
IP: Week 36
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-2.78 log10 IU/mL
Standard Error 0.198
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-3.35 log10 IU/mL
Standard Error 0.417
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-2.73 log10 IU/mL
Standard Error 0.150
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Change From Baseline Over Time in HBsAg Levels
CP: Week 12
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-3.51 log10 IU/mL
Standard Error 0.275
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-4.17 log10 IU/mL
Standard Error 0.444
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-3.53 log10 IU/mL
Standard Error 0.285
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Change From Baseline Over Time in HBsAg Levels
FU phase: Week 48
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-2.41 log10 IU/mL
Standard Error 0.364
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-3.14 log10 IU/mL
Standard Error 0.747
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-2.82 log10 IU/mL
Standard Error 0.425
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SECONDARY outcome
Timeframe: Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Change from baseline over time in HBsAg levels at specified timepoints were reported.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=24 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
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Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
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Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=15 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
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CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=24 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
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CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
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Change From Baseline Over Time in HBeAg Levels
IP: Week 36
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-1.78 log10 IU/mL
Standard Error 0.103
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-1.77 log10 IU/mL
Standard Error 0.151
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-1.49 log10 IU/mL
Standard Error 0.141
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—
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—
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—
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—
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—
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Change From Baseline Over Time in HBeAg Levels
CP: Week 12
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—
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—
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—
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-2.14 log10 IU/mL
Standard Error 0.146
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-2.39 log10 IU/mL
Standard Error 0.162
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-2.22 log10 IU/mL
Standard Error 0.234
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—
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—
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—
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Change From Baseline Over Time in HBeAg Levels
FU phase: Week 48
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—
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—
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—
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—
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—
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—
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-2.45 log10 IU/mL
Standard Error 0.243
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-2.59 log10 IU/mL
Standard Error 0.508
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-2.47 log10 IU/mL
Standard Error 0.278
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SECONDARY outcome
Timeframe: Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Change from baseline over time in HBV DNA Levels at Specified Timepoints were reported.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=25 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
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Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=15 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
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FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Over Time in HBV DNA Levels
IP: Week 36
|
-6.36 log10 IU/mL
Standard Error 0.218
|
-6.08 log10 IU/mL
Standard Error 0.202
|
-6.26 log10 IU/mL
Standard Error 0.231
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Over Time in HBV DNA Levels
CP: Week 12
|
—
|
—
|
—
|
-6.29 log10 IU/mL
Standard Error 0.205
|
-6.30 log10 IU/mL
Standard Error 0.350
|
-6.07 log10 IU/mL
Standard Error 0.269
|
—
|
—
|
—
|
|
Change From Baseline Over Time in HBV DNA Levels
FU phase: Week 48
|
—
|
—
|
—
|
—
|
—
|
—
|
-6.79 log10 IU/mL
Standard Error 0.203
|
-5.95 log10 IU/mL
Standard Error 0.563
|
-6.70 log10 IU/mL
Standard Error 0.257
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this endpoint. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
Time to achieve first HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ; HBsAg \<0.05 IU/mL) were reported. Time to HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance. Kaplan-Meier method was used for the estimation.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve First HBsAg Seroclearance
|
NA weeks
NA indicates that median \[90% CI\] data were not estimable due to insufficient number of participants with events.
|
NA weeks
Interval 6.1 to
NA indicates that median \[90% CI\] data were not estimable due to insufficient number of participants with events.
|
NA weeks
NA indicates that median \[90% CI\] data were not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
Time to achieve first occurrence of HBeAg seroclearance (HBeAg \<LLOQ \[\<0.11 IU/mL\]) were reported. Time to first occurrence of the HBeAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve First HBeAg Seroclearance
|
112 weeks
Interval 96.1 to
NA indicates that upper interval of CI data were not estimable due to insufficient number of participants with events.
|
100.3 weeks
Interval 48.0 to
NA indicates that upper interval of CI data were not estimable due to insufficient number of participants with events.
|
NA weeks
Interval 59.1 to
NA indicates that Median and upper interval of CI data were not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 of IP) to Follow-up Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure. Per planned analysis, data for this outcome measure was analyzed per pooled cohorts only.
Time to achieve first occurrence of HBV DNA \< LLOQ (\<20 IU/mL) were reported. Time to first occurrence of the HBV DNA \< LLOQ was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA \< LLOQ.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve First HBV DNA <LLOQ
|
35.9 weeks
Interval 28.1 to 52.1
|
53.3 weeks
Interval 12.1 to
NA indicates that lower interval of CI data were not estimable due to insufficient number of participants with events.
|
38.1 weeks
Interval 24.1 to 50.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: IP: Week 36, CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were : \<LLOQ (\<0.11 IU/mL), \< 1 IU/mL, \< 10 IU/mL, \<100 IU/mL
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=24 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=15 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=24 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
IP Week 36: <0.11 IU/mL
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
IP Week 36: <1 IU/mL
|
20.8 percentage of participants
|
14.3 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
IP Week 36: <10 IU/mL
|
54.2 percentage of participants
|
71.4 percentage of participants
|
46.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
IP Week 36: <100 IU/mL
|
91.7 percentage of participants
|
100.0 percentage of participants
|
86.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
CP Week 12: <0.11 IU/mL
|
—
|
—
|
—
|
12.5 percentage of participants
|
14.3 percentage of participants
|
17.6 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
CP Week 12: <1 IU/mL
|
—
|
—
|
—
|
37.5 percentage of participants
|
14.3 percentage of participants
|
47.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
CP Week 12: <10 IU/mL
|
—
|
—
|
—
|
75.0 percentage of participants
|
100.0 percentage of participants
|
76.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
CP Week 12: <100 IU/mL
|
—
|
—
|
—
|
95.8 percentage of participants
|
100.0 percentage of participants
|
94.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
FU Week 48: <0.11 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
28.0 percentage of participants
|
33.3 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
FU Week 48: <1 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
44.0 percentage of participants
|
50.0 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
FU Week 48: <10 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
80.0 percentage of participants
|
83.3 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants With HBeAg Levels Below Different Cut-offs
FU Week 48: <100IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
96.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: IP: Week 36, CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \<LLOQ (\<0.05 IU/mL), \<1 IU/mL, \<10 IU/mL, \<100 IU/mL, \<1000 IU/mL.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=25 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=15 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
FU Week 48: <1 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
11.5 percentage of participants
|
33.3 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
FU Week 48: <10 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
19.2 percentage of participants
|
50.0 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
CP Week 12: <100 IU/mL
|
—
|
—
|
—
|
60.0 percentage of participants
|
71.4 percentage of participants
|
76.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
CP Week 12: <1000 IU0/mL
|
—
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
FU Week 48: <0.05 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
11.5 percentage of participants
|
16.7 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
FU Week 48: <100 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
26.9 percentage of participants
|
50.0 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
FU Week 48: <1000 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
57.7 percentage of participants
|
66.7 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
IP Week 36: <0.05 IU/mL
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
IP Week 36: <1 IU/mL
|
4.0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
IP Week 36: <10 IU/mL
|
24.0 percentage of participants
|
42.9 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
IP Week 36: <100 IU/mL
|
40.0 percentage of participants
|
42.9 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
IP Week 36: <1000 IU/mL
|
88.0 percentage of participants
|
100.0 percentage of participants
|
86.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
CP Week 12: <0.05 IU/mL
|
—
|
—
|
—
|
8.0 percentage of participants
|
42.9 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
CP Week 12: <1 IU/mL
|
—
|
—
|
—
|
20.0 percentage of participants
|
42.9 percentage of participants
|
23.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBsAg Levels Below Different Cut-offs
CP Week 12: <10 IU/mL
|
—
|
—
|
—
|
40.0 percentage of participants
|
42.9 percentage of participants
|
47.1 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: IP: Week 36; CP: Week 12; FU phase: Week 48 (Week 112 [Cohort 1]; Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number of participants analyzed) signifies participants analyzed at specified categories. Here, n=0, signify that data were not collected and analyzed as that timepoint was not applicable to the respective arm.
Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \<LLOQ (\<20 IU/mL) for target detected and not detected, \< LLOQ for target not detected , and \< LLOQ for target detected, \<60 IU/mL, \<100 IU/mL, \<200 IU/mL, \<1000 IU/mL, \<2000 IU/mL, \<20000 IU/mL.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=25 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=7 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=15 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=6 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<LLOQ: target detected and not detected
|
—
|
—
|
—
|
32.0 percentage of participants
|
33.3 percentage of participants
|
29.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<200 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
|
83.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<LLOQ for target not detected
|
8.0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<LLOQ for target detected
|
44.0 percentage of participants
|
28.6 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<LLOQ target detected and not detected
|
52.0 percentage of participants
|
28.6 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<60 IU/mL
|
72.0 percentage of participants
|
57.1 percentage of participants
|
73.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<100 IU/mL
|
88.0 percentage of participants
|
57.1 percentage of participants
|
80.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<200 IU/mL
|
92.0 percentage of participants
|
71.4 percentage of participants
|
86.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<1000 IU/mL
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<2000 IU/mL
|
—
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<2000 IU/mL
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
IP Week 36:<20000 IU/mL
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<LLOQ for target not detected
|
—
|
—
|
—
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<1000 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
|
83.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<2000 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
|
83.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<LLOQ for target detected
|
—
|
—
|
—
|
32.0 percentage of participants
|
33.3 percentage of participants
|
29.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<20000 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<60 IU/mL
|
—
|
—
|
—
|
76.0 percentage of participants
|
50.0 percentage of participants
|
58.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<100 IU/mL
|
—
|
—
|
—
|
92.0 percentage of participants
|
83.3 percentage of participants
|
64.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<200 IU/mL
|
—
|
—
|
—
|
96.0 percentage of participants
|
83.3 percentage of participants
|
82.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<1000 IU/mL
|
—
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
CP Week 12:<20000 IU/mL
|
—
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<LLOQ target detected and not detected
|
—
|
—
|
—
|
—
|
—
|
—
|
84.6 percentage of participants
|
50.0 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48: <LLOQ for target not detected
|
—
|
—
|
—
|
—
|
—
|
—
|
34.6 percentage of participants
|
16.7 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<LLOQ for target detected
|
—
|
—
|
—
|
—
|
—
|
—
|
50.0 percentage of participants
|
33.3 percentage of participants
|
70.6 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<60 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
92.3 percentage of participants
|
50.0 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With HBV DNA Levels Below Different Cut-offs
FU Week 48:<100 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
|
66.7 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level \< LLOQ (\<20 IU/mL) or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level \<LLOQ of the HBV DNA assay. Confirmed HBV DNA increase/level means that the criterion was fulfilled at 2 or more consecutive time points or at the last observed on-treatment time point.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 Participants
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=17 Participants
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Breakthrough
|
3.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])Population: Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here N=0 signifies that data could not be analyzed due to insufficient number of participants with events.
Percentage of participants who reached HBV DNA undetectability after re-start of NA treatment during follow-up were reported. Undetectability of HBV DNA was defined as HBV DNA\<LLOQ that is \<20 IU/mL.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=27 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=8 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
n=19 Participants
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8Population: Pharmacokinetics analysis set (PK): included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Data for this outcome measure was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Cmax of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Noncompartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763976
|
1376 nanogram per milliliters (ng/mL)
Standard Deviation 1266
|
700 nanogram per milliliters (ng/mL)
Standard Deviation 227
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763924
|
279 nanogram per milliliters (ng/mL)
Standard Deviation 308
|
135 nanogram per milliliters (ng/mL)
Standard Deviation 39.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8Population: Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=8 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763976
|
5.53 hour
Interval 2.5 to 6.0
|
3.99 hour
Interval 2.98 to 6.0
|
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—
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Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763924
|
4.00 hour
Interval 0.5 to 5.73
|
2.99 hour
Interval 1.0 to 4.0
|
—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visitPopulation: Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this outcome measure. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Plasma concentration 24 hours after administration (C24h) of JNJ-73763989 (molecules: JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted to analyze C24h of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763976
|
315 ng/mL
Standard Deviation 213
|
381 ng/mL
Standard Deviation 155
|
—
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—
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—
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—
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—
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—
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—
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Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763924
|
36.9 ng/mL
Standard Deviation 27.9
|
54.7 ng/mL
Standard Deviation 25.0
|
—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visitPopulation: Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this outcome measure. Data for this endpoint was planned to be collected and analyzed as pooled cohort in induction phase and consolidation phase only.
Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (molecules:JNJ-73763976 \[JNJ3976\], JNJ-73763924 \[JNJ-3924\]) were reported. Non-compartmental analysis were conducted toanalyze AUC0 to 24h of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Cohort 1: JNJ-3989 200 mg+ JNJ-6379 250 mg+ NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
n=7 Participants
Prior to PA 5, participants enrolled in induction phase (IP)received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for \>=36 to \<=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week consolidation phase (CP) and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant who did not reach IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria (HBsAg \<10 IU/mL, HBeAg negative, and HBV DNA \<LLOQ and ALT \<3\*ULN) was met at CP Week 12, NA was stopped at FU phase Week 2, if NA treatment completion criteria was not met, NA was continued till end of FU phase.
|
Cohort 1: JNJ-3989 200 mg+ NA (245/25 mg) + PegIFNalpha-2a 180 mcg
n=6 Participants
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for \>=36 to \<=52 weeks. Per PA 5, the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5. After completion of IP, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA was continued till the end of FU phase.
|
Cohort 2: JNJ-3989 200 mg+ NA (245/25 mg)+ PegIFNalpha-2a 180 mcg
Participants enrolled as per PA 5 and 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met NA was continued till the end of FU phase.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFN-alpha-2a 180 mcg
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763976
|
19109 nanograms*hour per milliliters (ng*h/mL)
Standard Deviation 12482
|
12219 nanograms*hour per milliliters (ng*h/mL)
Standard Deviation 3499
|
—
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—
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—
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—
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—
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—
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—
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Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 Hours)] of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])
JNJ-73763924
|
3089 nanograms*hour per milliliters (ng*h/mL)
Standard Deviation 1964
|
2117 nanograms*hour per milliliters (ng*h/mL)
Standard Deviation 639
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—
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—
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—
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—
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—
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Adverse Events
IP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+ PegIFN-alpha-2a 180 mcg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
IP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+ PegIFN-alpha-2a 180 mcg
n=27 participants at risk
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for \>=36-weeks to \<=52-weeks.
|
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=8 participants at risk
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for \>=36-weeks to \<=52-weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
|
IP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=19 participants at risk
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 participants at risk
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=7 participants at risk
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=17 participants at risk
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 participants at risk
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=8 participants at risk
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU W2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=17 participants at risk
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
Other adverse events
| Measure |
IP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+ PegIFN-alpha-2a 180 mcg
n=27 participants at risk
Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for \>=36-weeks to \<=52-weeks.
|
IP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=8 participants at risk
In IP, participants (enrolled prior to PA 5) received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for \>=36-weeks to \<=52-weeks. Per PA 5 the end of IP was fixed to Week 36 or to the next planned visit following implementation of PA 5.
|
IP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=19 participants at risk
Participants enrolled as per PA 5 and 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=25 participants at risk
After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen for 12 weeks.
|
CP: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=7 participants at risk
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
CP: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=17 participants at risk
After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen for 12 weeks.
|
FU: Cohort 1: JNJ-3989 200 mg+JNJ-6379 250 mg+NA (245/25 mg)+PegIFN-alpha-2a 180 mcg
n=26 participants at risk
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 1: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=8 participants at risk
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU W2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
FU: Cohort 2: JNJ-3989 200 mg + NA (245/25 mg) + PegIFNalpha- 2a 180 mcg
n=17 participants at risk
After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
16.0%
4/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
28.6%
2/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
7.7%
2/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
28.0%
7/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
28.6%
2/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Eye disorders
Cataract
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Eye disorders
Eye Pruritus
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Eye disorders
Myopia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Nausea
|
14.8%
4/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
37.5%
3/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Asthenia
|
7.4%
2/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Chills
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Fatigue
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
25.0%
2/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
20.0%
5/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
28.6%
2/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
23.5%
4/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Hyperthermia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
16.0%
4/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
11.8%
2/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
7.7%
2/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.0%
3/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
17.6%
3/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Pain
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Rash
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Injury Associated with Device
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Pain
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
11.8%
2/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.0%
3/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
17.6%
3/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
General disorders
Temperature Intolerance
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Immune system disorders
Food Allergy
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Immune system disorders
Mite Allergy
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
25.0%
2/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Aspergilloma
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Conjunctivitis
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Covid-19
|
7.4%
2/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
25.0%
2/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
21.1%
4/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.0%
3/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
26.9%
7/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Influenza
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
2/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
15.4%
4/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
11.8%
2/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Paronychia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
25.0%
2/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Injury, poisoning and procedural complications
Skin Wound
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Alanine Aminotransferase Increased
|
29.6%
8/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
23.5%
4/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.4%
2/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
11.8%
2/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Blood Glucose Increased
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Body Temperature Increased
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Glucose Urine Present
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Liver Scan Abnormal
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Ultrasound Liver Abnormal
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
Weight Decreased
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.4%
2/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
11.8%
2/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.4%
2/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Limb Mass
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
8.0%
2/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
28.6%
2/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of Liver
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Nervous system disorders
Amnestic Disorder
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Nervous system disorders
Headache
|
18.5%
5/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
37.5%
3/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
20.0%
5/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
4.0%
1/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Sinusitis
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
10.5%
2/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
7.7%
2/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
11.8%
2/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
11.8%
2/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
3.7%
1/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
3.8%
1/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
12.5%
1/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
14.3%
1/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.3%
1/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/27 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/19 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/25 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/7 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
5.9%
1/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/26 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/8 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
0.00%
0/17 • IP: From Day 1 up to end of IP (up to Week 52 for Cohort 1; up to Week 36 for Cohort 2); CP: CP Week 1 up to CP Week 12 (for Cohort 1 and 2); FU phase: FU Week 1 up to FU Week 48 (up to Week 112 [Cohort 1]; up to Week 96 [Cohort 2])
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analyzed according to the study intervention they actually received.
|
Additional Information
Senior Director Medical Lead
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.
- Publication restrictions are in place
Restriction type: OTHER