Trial Outcomes & Findings for Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer (NCT NCT03250676)
NCT ID: NCT03250676
Last Updated: 2025-02-25
Results Overview
DLT was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with the study drug could not be ruled out: febrile neutropenia; Grade 4 neutropenia that was not resolved within 7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia lasting greater than (\>) 7 days or associated with clinically significant bleeding; Grade 4 vomiting and diarrhea; Grade 3 vomiting and diarrhea lasting \>72 hours despite treatment; Grade 4 electrolyte abnormality or Grade 3 abnormality lasting \>24 hours; Grade 3 or 4 serum creatinine or bilirubin increase; Grade 4 biochemistry or Grade 3 lasting \>7 days; Grade 4 or Grade 3 or intolerable Grade 2 toxicities of any non-hematologic adverse event.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Cycle 1 (Cycle length=28 days)
Results posted on
2025-02-25
Participant Flow
Participants took part in the study at 39 investigative sites in the United States, France, and the United Kingdom from 23 Aug 2017 to 26 Oct 2023. This study was conducted in two parts: dose escalation and dose expansion.
In the dose escalation part, a total of 47 participants were enrolled and received the study treatment and 104 participants were enrolled in the dose expansion part and received the study treatment. A food-effect sub-study was conducted during the dose expansion phase, where a total of 18 participants (9 participants in each intervention sequence) received H3B-6545 under fed and fasted conditions in a cross-over manner and aided in evaluation of pharmacokinetic (PK) data.
Participant milestones
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
Participants received H3B-6545 100 milligram (mg) capsule, orally, once daily (QD) in each 28-days cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 2: Dose Expansion: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
11
|
11
|
7
|
104
|
|
Overall Study
Food-effect Cohort - Fasted Then Fed
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Overall Study
Food-effect Cohort - Fed Then Fasted
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
11
|
11
|
7
|
104
|
Reasons for withdrawal
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
Participants received H3B-6545 100 milligram (mg) capsule, orally, once daily (QD) in each 28-days cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 2: Dose Expansion: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
3
|
|
Overall Study
Withdrawal of consent
|
0
|
0
|
2
|
0
|
0
|
2
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease progression
|
4
|
12
|
9
|
7
|
4
|
88
|
Baseline Characteristics
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=11 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 2: Dose Expansion: H3B-6545 450 mg
n=104 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
61 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
104 Participants
n=8 Participants
|
151 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
143 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
84 Participants
n=8 Participants
|
127 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Cycle length=28 days)Population: Dose evaluable set included all participants who were evaluated for DLTs in dose escalation part.
DLT was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with the study drug could not be ruled out: febrile neutropenia; Grade 4 neutropenia that was not resolved within 7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia lasting greater than (\>) 7 days or associated with clinically significant bleeding; Grade 4 vomiting and diarrhea; Grade 3 vomiting and diarrhea lasting \>72 hours despite treatment; Grade 4 electrolyte abnormality or Grade 3 abnormality lasting \>24 hours; Grade 3 or 4 serum creatinine or bilirubin increase; Grade 4 biochemistry or Grade 3 lasting \>7 days; Grade 4 or Grade 3 or intolerable Grade 2 toxicities of any non-hematologic adverse event.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=10 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=10 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=5 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of progressive disease (PD) or death, whichever occurred first (up to 33 months)Population: Response-evaluable set included those participants who received at least 1 dose of study drug and had measurable disease at baseline and at least 1 post-baseline evaluation.
ORR was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as defined by the Investigator based on radiologic criteria. ORR was defined as the percentage of participants who achieved a best overall response of confirmed partial response (PR) or complete response (CR). CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to less than (\<)10 millimeter (mm). PR was defined as at least a 30 percentage (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg dose was presented as enrolled participants in both the phases had similar demographics and disease characteristics.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=11 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=10 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=94 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=5 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Objective Response Rate (ORR)
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
0 percentage of participants
Interval 0.0 to 30.8
|
20.2 percentage of participants
Interval 12.6 to 29.8
|
0 percentage of participants
Interval 0.0 to 52.2
|
PRIMARY outcome
Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)Population: Response-evaluable set included those participants who received at least 1 dose of study drug and had measurable disease at baseline and at least 1 post-baseline evaluation. Here, "Overall number of participants analyzed" signifies participants who had CR or/and PR.
The DoR was assessed according to RECIST version 1.1. DoR was defined as the time from the date of the first documented CR/PR until the first documentation of disease progression or death, whichever comes first. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=1 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=1 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=19 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Duration of Response (DoR)
|
7.95 months
Upper and lower range of 95% confidence interval (CI) could not be estimated due to insufficient events.
|
6.05 months
Upper and lower range of 95% CI could not be estimated due to insufficient events.
|
—
|
9.23 months
Interval 5.88 to 20.24
|
—
|
PRIMARY outcome
Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)Population: Response-evaluable set included those participants who received at least 1 dose of study drug and had measurable disease at baseline and at least 1 post-baseline evaluation.
The DCR was assessed according to RECIST version 1.1. DCR was defined as the percentage of participants who achieved best response of CR, PR, or stable disease (SD). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters while on study. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=11 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=10 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=94 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=5 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Disease Control Rate (DCR)
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
54.5 percentage of participants
Interval 23.4 to 83.3
|
30.0 percentage of participants
Interval 6.7 to 65.2
|
61.7 percentage of participants
Interval 51.1 to 71.5
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
PRIMARY outcome
Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)Population: Response-evaluable set included those participants who received at least 1 dose of study drug and had measurable disease at baseline and at least 1 post-baseline evaluation.
The CBR was assessed according to RECIST version 1.1. CBR defined as the percentage of participants with best overall response (BOR) of PR, CR, or durable SD (duration \>=23 weeks). It was calculated for participants whose BOR was SD. CR defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters on study. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=11 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=10 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=94 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=5 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Clinical Benefit Rate (CBR)
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
20.0 percentage of participants
Interval 2.5 to 55.6
|
41.5 percentage of participants
Interval 31.4 to 52.1
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
PRIMARY outcome
Timeframe: Phase 1 and Phase 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 33 months)Population: Full analysis set included all participants who received at least 1 dose of study drug.
PFS was defined as the time from the first dose date to the date of the first documentation of PD or death whichever occurred first. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=115 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Progression-free Survival (PFS)
|
9.28 months
Interval 7.43 to
Upper range of 95% CI could not be estimated due to higher number (\>50%) of censored participants.
|
3.38 months
Interval 1.31 to 7.75
|
1.84 months
Interval 1.61 to 5.36
|
4.60 months
Interval 3.52 to 6.67
|
2.76 months
Interval 0.49 to 5.32
|
PRIMARY outcome
Timeframe: Phase 1 and Phase 2: From the first dose of study drug to date of death or last known alive (up to 63 months)Population: Full analysis set included all participants who received at least 1 dose of study drug.
OS was defined as the time from first dose date to the date of death (event) or date last known alive (censored). As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=115 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Overall Survival (OS)
|
12.37 months
Interval 7.43 to
Upper range of 95% CI could not be estimated due to higher number (\>50%) of censored participants.
|
11.25 months
Interval 1.87 to 40.41
|
13.50 months
Interval 2.37 to 27.6
|
21.52 months
Interval 16.56 to 25.46
|
5.32 months
Interval 2.33 to 11.56
|
SECONDARY outcome
Timeframe: From start of the study up to 74 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of study drug.
TEAE was defined per NCI CTCAE version 4.03 as an adverse event (AE) with an onset that occurred after receiving study drug. An AE was defined as any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. Pooled data from phase 1 and phase 2 was presented for 450 mg arm as enrolled participants in both the phases had similar demographics and disease characteristics with no major changes in inclusion/exclusion criteria as defined in the protocol.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=115 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
1 Participants
|
2 Participants
|
30 Participants
|
1 Participants
|
|
Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
6 Participants
|
12 Participants
|
11 Participants
|
115 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length = 28 days)Population: PK analysis set included all participants who had received at least 1 dose of study drug H3B-6545 and had sufficient PK data to derive at least 1 PK parameter. Here, "number analyzed" signifies participants who were evaluable for specified timepoints.
AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 time to last measurable point for H3B-6545.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=11 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1: (AUC0-t): Area Under the Plasma Concentration-time Curve From Time 0 Through the Last Measurable Point of H3B-6545
Cycle 1 Day 1
|
1680 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 85.4
|
3310 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 66.5
|
8520 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 49.0
|
16200 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 43.2
|
12600 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 512
|
|
Phase 1: (AUC0-t): Area Under the Plasma Concentration-time Curve From Time 0 Through the Last Measurable Point of H3B-6545
Cycle 1 Day 15
|
2590 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 57.4
|
5200 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 70.6
|
10700 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 50.3
|
14100 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 53.2
|
14900 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 99.5
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length = 28 days)Population: PK analysis set included all participants who had received at least 1 dose of study drug H3B-6545 and had sufficient PK data to derive at least 1 PK parameter. Here, "number analyzed" signifies participants who were evaluable for specified timepoints.
Cmax was defined as the maximum plasma concentration for H3B-6545.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=11 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1: Cmax: Maximum Observed Plasma Concentration for H3B-6545
Cycle 1 Day 1
|
178 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 85.3
|
391 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.7
|
879 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.5
|
1500 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.1
|
1490 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 167
|
|
Phase 1: Cmax: Maximum Observed Plasma Concentration for H3B-6545
Cycle 1 Day 15
|
287 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31.3
|
605 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56.0
|
1200 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.2
|
1410 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.5
|
1310 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 129
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length = 28 days)Population: PK analysis set included all participants who had received at least 1 dose of study drug H3B-6545 and had sufficient PK data to derive at least 1 PK parameter. Here, "number analyzed" signifies participants who were evaluable for specified timepoints.
Tmax was defined as the time to reach maximum observed plasma concentration for H3B-6545.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=11 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1: Tmax: Time of Maximum Observed Plasma Concentration of H3B-6545
Cycle 1 Day 1
|
3.05 hours
Interval 2.0 to 6.0
|
3.00 hours
Interval 2.0 to 6.17
|
3.97 hours
Interval 2.0 to 6.0
|
4.00 hours
Interval 2.0 to 10.0
|
4.00 hours
Interval 2.0 to 6.0
|
|
Phase 1: Tmax: Time of Maximum Observed Plasma Concentration of H3B-6545
Cycle 1 Day 15
|
2.00 hours
Interval 2.0 to 8.03
|
2.17 hours
Interval 2.0 to 6.0
|
4.00 hours
Interval 2.0 to 5.95
|
4.00 hours
Interval 1.0 to 8.0
|
5.00 hours
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length = 28 days)Population: PK analysis set included all participants who had received at least 1 dose of study drug H3B-6545 and had sufficient PK data to derive at least 1 PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Accumulation ratio of Cmax was calculated as Cmax at Cycle 1 Day 15/Cmax at Cycle 1 Day 1.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=10 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=10 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=2 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1: Rac (Cmax): Accumulation Ratio of Cmax for H3B-6545
|
1.61 ratio
Geometric Coefficient of Variation 69.3
|
1.52 ratio
Geometric Coefficient of Variation 80.6
|
1.37 ratio
Geometric Coefficient of Variation 35.8
|
1.05 ratio
Geometric Coefficient of Variation 42.1
|
0.598 ratio
Geometric Coefficient of Variation 98.0
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose (Cycle length = 28 days)Population: PK analysis set included all participants who had received at least 1 dose of study drug H3B-6545 and had sufficient PK data to derive at least 1 PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Rac (AUC0-24h) was calculated as AUC(0-24h) at Cycle 1 Day 15/AUC(0-24h) at Cycle 1 Day 1.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=8 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=9 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=10 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=2 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1: Rac (AUC0-24h): Accumulation Ratio of Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24h) for H3B-6545
|
1.52 ratio
Geometric Coefficient of Variation 58.3
|
1.55 ratio
Geometric Coefficient of Variation 77.8
|
1.23 ratio
Geometric Coefficient of Variation 26.1
|
0.917 ratio
Geometric Coefficient of Variation 48.5
|
0.646 ratio
Geometric Coefficient of Variation 37.5
|
SECONDARY outcome
Timeframe: Cycle 1 Days 15 and 22: predose and up to 24 hours postdose (Cycle length = 28 days)Population: Food-effect analysis set included all participants who were assigned to the food-effect cohort and had sufficient PK data to derive at least 1 PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Relative bioavailability based on food effect was calculated by taking ratio of AUC(0-24h) under fed condition divided by AUC(0-24h) under fasting condition. Data for the fasted and fed cohorts was collected on both Day 15 and Day 22 and was averaged.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=13 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 2: Relative Bioavailability (Food Effect) of H3B-6545 Assessed Using AUC(0-24h)
|
1.53 ratio
Interval 1.19 to 1.98
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 15 and 22: predose and up to 24 hours postdose (Cycle length = 28 days)Population: Food-effect analysis set included all participants who were assigned to the food-effect cohort and had sufficient PK data to derive at least 1 PK parameter.
Relative bioavailability based on food effect was calculated by taking ratio of Cmax under fed condition divided by Cmax under fasting condition. Data for the fasted and fed cohorts was collected on both Day 15 and Day 22 and was averaged.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=18 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 2: Relative Bioavailability (Food Effect) of H3B-6545 Assessed Using Cmax
|
1.51 ratio
Interval 1.2 to 1.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36 and Week 60Population: Endometrium safety evaluable set included all participants with intact uteri at baseline, who received at least 1 dose of study drug and had ultrasound assessments at screening/baseline and three months after starting trial therapy. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "Number analyzed" signifies participants who were evaluable for specified timepoints.
Participants with an intact uterus underwent transvaginal ultrasound to examine the effect of H3B-6545 on endometrial thickness. Baseline was defined as the last non-missing value before the first dose of study drug (Day 1). Mean change from baseline was calculated as post-baseline visit value minus baseline value.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=24 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 2: Mean Change From Baseline in Endometrial Thickness Due to H3B-6545
At Week 12
|
4.079 millimeter
Standard Deviation 4.9659
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Endometrial Thickness Due to H3B-6545
At Week 36
|
5.400 millimeter
Standard Deviation 6.9931
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Endometrial Thickness Due to H3B-6545
At Week 60
|
-0.050 millimeter
Standard Deviation 0.0707
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 36Population: Endometrium safety evaluable set included all participants with intact uteri at baseline, who received at least 1 dose of study drug and had ultrasound assessments at screening/baseline and three months after starting trial therapy. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "Number analyzed" signifies participants who were evaluable for specified timepoints.
Participants with an intact uterus underwent transvaginal ultrasound to examine the effect of H3B-6545 on uterine volume. Baseline was defined as the last non-missing value before the first dose of study drug (Day 1). Mean change from baseline was calculated as post-baseline visit value minus baseline value.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=24 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 2: Mean Change From Baseline in Uterine Volume Due to H3B-6545
At Week 12
|
66.822 milliliter
Standard Deviation 63.7151
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Uterine Volume Due to H3B-6545
At Week 36
|
41.083 milliliter
Standard Deviation 60.6320
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose), Cycle 2 Day 15, Cycle 4 Day 1, and off-Treatment (up to 33 months) (Cycle length = 28 days)Population: Bone turnover markers-evaluable set included participants who had baseline/screening assessments of bone turnover markers and at least 1 additional assessment at 6 and/or 12 weeks after starting trial therapy. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable for specified timepoints.
Blood samples were collected at indicated timepoint for evaluation of bone turn-over marker BSAP. Baseline is defined as the last non-missing value before the first dose of study drug (Day1). Change from baseline was calculated as post-baseline visit value minus baseline value. Pooled data from phase 1 and phase 2 was presented for 450 mg arm as enrolled participants in both the phases had similar demographics and disease characteristics with no major changes in inclusion/exclusion criteria as defined in the protocol.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=3 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=3 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=75 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=3 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - Bone-specific Alkaline Phosphatase
Cycle 2 Day 15
|
—
|
-5.543 units per liter (U/L)
Standard Deviation 14.7690
|
2.327 units per liter (U/L)
Standard Deviation 4.5368
|
5.912 units per liter (U/L)
Standard Deviation 40.7469
|
-5.683 units per liter (U/L)
Standard Deviation 5.4399
|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - Bone-specific Alkaline Phosphatase
Cycle 4 Day 1
|
—
|
-0.390 units per liter (U/L)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
—
|
0.381 units per liter (U/L)
Standard Deviation 33.6782
|
-0.900 units per liter (U/L)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - Bone-specific Alkaline Phosphatase
Off-Treatment
|
—
|
—
|
—
|
-4.469 units per liter (U/L)
Standard Deviation 37.2991
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose), Cycle 2 Day 15, Cycle 4 Day 1, and off-Treatment (up to 33 months) (Cycle length = 28 days)Population: Bone turnover markers-evaluable set included participants who had baseline/screening assessments of bone turnover markers and at least 1 additional assessment at 6 and/or 12 weeks after starting trial therapy. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable for specified timepoints.
Blood samples were collected at indicated timepoint for evaluation of Bone turn-over marker PINP. Baseline is defined as the last non-missing value before the first dose of study drug (Day 1). Change from baseline was calculated as post-baseline visit value minus baseline value. Pooled data from phase 1 and phase 2 was presented for 450 mg arm as enrolled participants in both the phases had similar demographics and disease characteristics with no major changes in inclusion/exclusion criteria as defined in the protocol.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=4 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=9 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=6 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=81 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=3 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - Amino-Terminal Propeptide of Type 1 Collagen (PINP)
Cycle 2 Day 15
|
-32.750 micrograms per liter (mcg/L)
Standard Deviation 61.6786
|
-14.139 micrograms per liter (mcg/L)
Standard Deviation 40.4722
|
53.568 micrograms per liter (mcg/L)
Standard Deviation 104.0942
|
26.242 micrograms per liter (mcg/L)
Standard Deviation 154.4307
|
38.750 micrograms per liter (mcg/L)
Standard Deviation 60.3179
|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - Amino-Terminal Propeptide of Type 1 Collagen (PINP)
Cycle 4 Day 1
|
-35.500 micrograms per liter (mcg/L)
Standard Deviation 67.9828
|
-13.967 micrograms per liter (mcg/L)
Standard Deviation 43.6322
|
-94.000 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
3.555 micrograms per liter (mcg/L)
Standard Deviation 119.9087
|
10.170 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - Amino-Terminal Propeptide of Type 1 Collagen (PINP)
Off-Treatment
|
—
|
-3.560 micrograms per liter (mcg/L)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
—
|
-22.920 micrograms per liter (mcg/L)
Standard Deviation 71.8744
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose), Cycle 2 Day 15, Cycle 4 Day 1, and off-Treatment (up to 33 months) (Cycle length = 28 days)Population: Bone turnover markers-evaluable set included participants who had baseline/screening assessments of bone turnover markers and at least 1 additional assessment at 6 and/or 12 weeks after starting trial therapy. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable for specified timepoints.
Blood samples were collected at indicated timepoint for evaluation of Bone turn-over marker CTX. Baseline is defined as the last non-missing value before the first dose of study drug (Day 1). Change from baseline was calculated as post-baseline visit value minus baseline value. Pooled data from phase 1 and phase 2 was presented for 450 mg arm as enrolled participants in both the phases had similar demographics and disease characteristics with no major changes in inclusion/exclusion criteria as defined in the protocol.
Outcome measures
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=5 Participants
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=9 Participants
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=6 Participants
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 450 mg
n=81 Participants
Participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=3 Participants
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)
Cycle 2 Day 15
|
0.034 nanograms per millilitre (ng/mL)
Standard Deviation 0.1648
|
0.024 nanograms per millilitre (ng/mL)
Standard Deviation 0.1038
|
-0.270 nanograms per millilitre (ng/mL)
Standard Deviation 0.3861
|
0.047 nanograms per millilitre (ng/mL)
Standard Deviation 0.4330
|
-0.036 nanograms per millilitre (ng/mL)
Standard Deviation 0.1976
|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)
Cycle 4 Day 1
|
0.028 nanograms per millilitre (ng/mL)
Standard Deviation 0.2529
|
-0.008 nanograms per millilitre (ng/mL)
Standard Deviation 0.1743
|
-0.549 nanograms per millilitre (ng/mL)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
0.021 nanograms per millilitre (ng/mL)
Standard Deviation 0.3562
|
0.009 nanograms per millilitre (ng/mL)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
|
Phase 1 and 2: Change From Baseline in Bone Turn-over Marker - C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)
Off-Treatment
|
—
|
-0.184 nanograms per millilitre (ng/mL)
Standard Deviation NA
Standard deviation could not be estimated due to insufficient number of participants.
|
—
|
-0.148 nanograms per millilitre (ng/mL)
Standard Deviation 0.3735
|
—
|
Adverse Events
Phase 1: Dose Escalation: H3B-6545 100 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 1: Dose Escalation: H3B-6545 200 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 10 deaths
Phase 1: Dose Escalation: H3B-6545 300 mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 11 deaths
Phase 1 and Phase 2: H3B-6545 450 mg
Serious events: 30 serious events
Other events: 114 other events
Deaths: 83 deaths
Phase 1: Dose Escalation: H3B-6545 600 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 participants at risk
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 participants at risk
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 participants at risk
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1 and Phase 2: H3B-6545 450 mg
n=115 participants at risk
In Phase 1 (dose-escalation) and Phase 2 (dose expansion), participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 participants at risk
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar lung disease
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
Other adverse events
| Measure |
Phase 1: Dose Escalation: H3B-6545 100 mg
n=6 participants at risk
Participants received H3B-6545 100 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 200 mg
n=12 participants at risk
Participants received H3B-6545 200 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1: Dose Escalation: H3B-6545 300 mg
n=11 participants at risk
Participants received H3B-6545 300 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
Phase 1 and Phase 2: H3B-6545 450 mg
n=115 participants at risk
In Phase 1 (dose-escalation) and Phase 2 (dose expansion), participants received H3B-6545 450 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Dose Escalation: H3B-6545 600 mg
n=7 participants at risk
Participants received H3B-6545 600 mg capsule, orally, QD in each 28-days treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or study discontinuation.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
3/6 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
33.3%
4/12 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
45.5%
5/11 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
33.9%
39/115 • Number of events 118 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
57.1%
4/7 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
5.2%
6/115 • Number of events 11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
6.1%
7/115 • Number of events 9 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
50.0%
6/12 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
72.7%
8/11 • Number of events 8 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
45.2%
52/115 • Number of events 71 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Photopsia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Visual field defect
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.6%
11/115 • Number of events 15 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
10.4%
12/115 • Number of events 14 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
28.6%
2/7 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
47.0%
54/115 • Number of events 76 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Glossitis
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
33.3%
4/12 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
36.4%
4/11 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
47.8%
55/115 • Number of events 69 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
57.1%
4/7 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
26.1%
30/115 • Number of events 48 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
28.6%
2/7 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Axillary pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Chest pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Chills
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Facial pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
33.3%
4/12 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
36.5%
42/115 • Number of events 69 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
28.6%
2/7 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Malaise
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Nodule
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Cardiac murmur
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.8%
17/115 • Number of events 18 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
5.2%
6/115 • Number of events 8 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.0%
8/115 • Number of events 13 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Suprapubic pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
General disorders
Thirst decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Body tinea
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Tongue fungal infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
3/6 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.8%
17/115 • Number of events 25 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Vestibulitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
41.7%
5/12 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
13.9%
16/115 • Number of events 32 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
28.6%
2/7 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
41.7%
5/12 • Number of events 11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
15.7%
18/115 • Number of events 31 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
57.1%
4/7 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.0%
8/115 • Number of events 9 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.7%
10/115 • Number of events 22 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
42.9%
3/7 • Number of events 8 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
28.6%
2/7 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Blood zinc decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
11.3%
13/115 • Number of events 21 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 8 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.7%
10/115 • Number of events 18 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
Weight increased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
25.0%
3/12 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
12.2%
14/115 • Number of events 15 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
5.2%
6/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
33.3%
4/12 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
5.2%
6/115 • Number of events 8 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
28.6%
2/7 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 8 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
6.1%
7/115 • Number of events 10 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
4/6 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
13.9%
16/115 • Number of events 22 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
3/6 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
12.2%
14/115 • Number of events 16 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.0%
8/115 • Number of events 10 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
2/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
5.2%
6/115 • Number of events 12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.0%
8/115 • Number of events 9 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.6%
11/115 • Number of events 21 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
6.1%
7/115 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
41.7%
5/12 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
17.4%
20/115 • Number of events 24 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
6.1%
7/115 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.8%
17/115 • Number of events 18 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Nervous system disorders
Visual perseveration
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.8%
9/115 • Number of events 10 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 5 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
6.1%
7/115 • Number of events 7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Pica
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
3.5%
4/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Reproductive system and breast disorders
Hydrometra
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
5.2%
6/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.8%
17/115 • Number of events 22 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.5%
19/115 • Number of events 28 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
6.1%
7/115 • Number of events 10 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
2.6%
3/115 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.8%
17/115 • Number of events 18 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
42.9%
3/7 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.7%
10/115 • Number of events 14 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.0%
8/115 • Number of events 13 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
14.3%
1/7 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
16.7%
1/6 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/115 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
1.7%
2/115 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Skin and subcutaneous tissue disorders
Vascular skin disorder
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.87%
1/115 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/12 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
9.1%
1/11 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 2 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
27.3%
3/11 • Number of events 3 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.0%
8/115 • Number of events 8 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
16.7%
2/12 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
18.2%
2/11 • Number of events 4 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
7.8%
9/115 • Number of events 14 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
8.3%
1/12 • Number of events 1 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/11 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
4.3%
5/115 • Number of events 6 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
0.00%
0/7 • From start of the study up to 74 months
The safety analysis set included all participants who had received at least 1 dose of study drug. As per planned analysis, pooled data for phase 1 and phase 2 for 450 mg arm was presented as enrolled participants in both the phases had similar demographics and disease characteristics. As per planned analysis the food-effect cohort of the Phase 2 only analyzed the effect of food (high-fat meal) on H3B-6545 pharmacokinetics, and no safety analyses was planned for the food-effect cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place