Trial Outcomes & Findings for Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma (NCT NCT01794520)
NCT ID: NCT01794520
Last Updated: 2023-04-10
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
117 participants
Primary outcome timeframe
From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)
Results posted on
2023-04-10
Participant Flow
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug
Participant milestones
| Measure |
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
6
|
9
|
36
|
20
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
6
|
9
|
36
|
20
|
31
|
Reasons for withdrawal
| Measure |
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse events- related to progression
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
Adverse event- not related to progression
|
1
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Progressive disease
|
5
|
6
|
2
|
5
|
27
|
18
|
0
|
|
Overall Study
Withdrew consent
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Toxicity
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
1
|
0
|
1
|
0
|
7
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
22
|
|
Overall Study
Other, not specified
|
0
|
0
|
1
|
1
|
4
|
1
|
2
|
Baseline Characteristics
Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1: Venetoclax 300 mg
n=6 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=9 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=6 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=9 Participants
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=36 Participants
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=20 Participants
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=31 Participants
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 7.32 • n=93 Participants
|
63.1 years
STANDARD_DEVIATION 9.03 • n=4 Participants
|
61.8 years
STANDARD_DEVIATION 12.06 • n=27 Participants
|
67.3 years
STANDARD_DEVIATION 8.32 • n=483 Participants
|
60.8 years
STANDARD_DEVIATION 10.58 • n=36 Participants
|
63.4 years
STANDARD_DEVIATION 8.13 • n=10 Participants
|
64.9 years
STANDARD_DEVIATION 8.31 • n=115 Participants
|
63.1 years
STANDARD_DEVIATION 9.25 • n=40 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
52 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
17 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
65 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
17 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
100 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
11 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Multi Race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)Population: Safety population: all participants who received at least one dose of study drug
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=6 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=9 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=6 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=9 Participants
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=36 Participants
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=20 Participants
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=31 Participants
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any TEAE
|
6 Participants
|
9 Participants
|
6 Participants
|
9 Participants
|
36 Participants
|
19 Participants
|
30 Participants
|
|
Number of Participants With Adverse Events
TESAE
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
6 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdosePopulation: Phase 1 dose escalation and safety expansion participants with available data
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=6 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=5 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=4 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=12 Participants
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax
|
0.897 µg/mL
Standard Deviation 0.593
|
2.56 µg/mL
Standard Deviation 1.77
|
1.85 µg/mL
Standard Deviation 1.30
|
4.16 µg/mL
Standard Deviation 1.52
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdosePopulation: Phase 1 dose escalation and safety expansion participants with available data
Tmax is the the time at which the maximum plasma concentration (Cmax) is observed.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=6 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=5 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=4 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=12 Participants
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
|
5.0 hours
Interval 2.0 to 8.0
|
8.0 hours
Interval 2.7 to 8.0
|
6.0 hours
Interval 4.0 to 8.0
|
6.1 hours
Interval 4.0 to 8.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose (dose escalation cohort); (1200 mg dose): Cycle 2, Day 1 at predose (safety expansion cohort, 1200 mg dose)Population: Phase 1 dose escalation and safety expansion participants with available data
AUC is a measure of how long and how much drug is present in the body after dosing.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=6 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=5 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=3 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=9 Participants
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax
|
13.0 µg•h/mL
Standard Deviation 8.31
|
38.2 µg•h/mL
Standard Deviation 25.1
|
26.3 µg•h/mL
Standard Deviation 20.1
|
71.5 µg•h/mL
Standard Deviation 35.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 monthsPopulation: All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; primary efficacy endpoints were pre-specified for Phase 2 only, and are reported for all participants with available data
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response \[VGPR\], Complete response \[CR\], or Stringent complete response \[sCR\]) per 2016 standard International Myeloma Working Group (IMWG) criteria.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=31 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate
|
48.4 percentage of participants
Interval 30.2 to 66.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 monthsPopulation: All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; primary efficacy endpoints were pre-specified for Phase 2 only, and are reported for all participants with available data
The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response \[CR\], or Stringent complete response \[sCR\]) per 2016 standard International Myeloma Working Group (IMWG) criteria was computed.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=31 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Very Good Partial Response Rate or Better
|
35.5 percentage of participants
Interval 19.2 to 54.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 8.1 monthsPopulation: All enrolled Phase 1 participants who had active disease at baseline and received venetoclax
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response \[VGPR\], Complete response \[CR\], or Stringent complete response \[sCR\]) per 2011 International Myeloma Working Group (IMWG) criteria.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=6 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=9 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=6 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=9 Participants
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=36 Participants
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=20 Participants
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Overall Response Rate
|
0 percentage of participants
Interval 0.0 to 45.9
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0 percentage of participants
Interval 0.0 to 33.6
|
36.1 percentage of participants
Interval 20.8 to 53.8
|
65.0 percentage of participants
Interval 40.8 to 84.6
|
—
|
SECONDARY outcome
Timeframe: Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; Estimated median time on follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2Population: All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response (PR or better)
TTR is defined as the number of days from the date of first dose of study drug until the date of their first favorable response of Partial Response (PR) or better (PR, Very good partial response \[VGPR\], Complete response \[CR\], or Stringent complete response \[sCR\]) per 2011 International Myeloma Working Group (IMWG) criteria (Phase 1) or 2016 IMWG criteria (Phase 2). If a participant did not experience a favorable response, they were to be censored at the date of last adequate assessment. TTR was analyzed by Kaplan- Meier (K-M)\\ methodology.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=1 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=1 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=13 Participants
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=13 Participants
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=15 Participants
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Time to Response (TTR)
|
—
|
NA months
Interval 1.9 to
Not estimable/calculable due to low number of participants with events
|
NA months
Interval 1.2 to
Not estimable/calculable due to low number of participants with events
|
—
|
9.0 months
Interval 1.9 to
Not estimable/calculable due to low number of participants with events
|
2.6 months
Interval 1.4 to
Not estimable/calculable due to low number of participants with events
|
0.8 months
Interval 0.7 to
Not estimable/calculable due to low number of participants with events
|
SECONDARY outcome
Timeframe: Estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2Population: All enrolled participants who received venetoclax
TTP is defined as the number of days from the date of first dose of study drug to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan- Meier (K-M) methodology.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=6 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=9 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=6 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=9 Participants
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=36 Participants
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=20 Participants
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=31 Participants
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
5.0 months
Interval 3.9 to
Not estimable/calculable due to low number of participants with events
|
2.0 months
Interval 0.5 to
Not estimable/calculable due to low number of participants with events
|
1.2 months
Interval 0.4 to
Not estimable/calculable due to low number of participants with events
|
1.9 months
Interval 0.5 to
Not estimable/calculable due to low number of participants with events
|
4.2 months
Interval 1.9 to 10.2
|
12.2 months
Interval 4.2 to 20.9
|
11.2 months
Interval 5.2 to 18.4
|
SECONDARY outcome
Timeframe: Assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2Population: All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response of PR or better
DOR is defined as the number of days from the date of first response of Partial Response (PR) or better to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan- Meier (K-M) methodology.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=1 Participants
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=1 Participants
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=13 Participants
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=13 Participants
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=15 Participants
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Duration of Response
|
—
|
9.7 months
Not estimable/calculable due to low number of participants with events
|
NA months
Not estimable/calculable due to low number of participants with events
|
—
|
17.3 months
Interval 7.8 to 27.0
|
13.1 months
Interval 5.7 to 21.9
|
17.5 months
Interval 7.6 to 28.8
|
SECONDARY outcome
Timeframe: Estimated median duration of follow-up was 31.7 monthsPopulation: All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; this endpoint was pre-specified for Phase 2 only, data are reported for all participants with available data
PFS is defined as the number of days from the date of the first dose of study treatment to the date of first documented disease progression or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=31 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Progression-Free Survival (PFS)
|
11.2 months
Interval 5.2 to 18.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Estimated median duration of follow-up was 31.7 monthsPopulation: All enrolled Phase 2 participants who received venetoclax; this endpoint was pre-specified for Phase 2 only, data are reported for all participants with available data
OS is defined as the number of days from the date of the first dose of study drug to the date of death due to any cause. If a participant was not known to have died, OS was censored at the last known alive date. The distribution of OS was estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=31 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
18.4 months
Interval 8.2 to 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visitPopulation: Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=16 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 3, Day 1
|
0.2 units on a scale
Standard Deviation 2.47
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 5, Day 1
|
-0.9 units on a scale
Standard Deviation 1.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 7, Day 1
|
-0.9 units on a scale
Standard Deviation 1.20
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 9, Day 1
|
-0.9 units on a scale
Standard Deviation 1.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 11, Day 1
|
-1.1 units on a scale
Standard Deviation 1.62
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 13, Day 1
|
0.5 units on a scale
Standard Deviation 3.84
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 15, Day 1
|
-0.6 units on a scale
Standard Deviation 1.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 17, Day 1
|
-1.6 units on a scale
Standard Deviation 1.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 19, Day 1
|
-1.8 units on a scale
Standard Deviation 2.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 21, Day 1
|
-1.6 units on a scale
Standard Deviation 2.30
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 23, Day 1
|
-1.6 units on a scale
Standard Deviation 2.30
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Cycle 25, Day 1
|
-3.8 units on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Final visit
|
-0.3 units on a scale
Standard Deviation 1.86
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visitPopulation: Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=16 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 23, Day 1
|
-3.3 units on a scale
Standard Deviation 14.14
|
—
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—
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—
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—
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—
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—
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Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 3, Day 1
|
-3.7 units on a scale
Standard Deviation 21.90
|
—
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—
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—
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—
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—
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—
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Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 5, Day 1
|
4.0 units on a scale
Standard Deviation 15.78
|
—
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—
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—
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—
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—
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—
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Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 7, Day 1
|
8.3 units on a scale
Standard Deviation 11.13
|
—
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—
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—
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—
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—
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—
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Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 9, Day 1
|
8.3 units on a scale
Standard Deviation 11.13
|
—
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—
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—
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—
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—
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—
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Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 11, Day 1
|
15.2 units on a scale
Standard Deviation 9.97
|
—
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—
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—
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—
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—
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—
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Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 13, Day 1
|
11.4 units on a scale
Standard Deviation 14.76
|
—
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—
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—
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—
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—
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—
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Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 15, Day 1
|
14.3 units on a scale
Standard Deviation 11.17
|
—
|
—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 17, Day 1
|
8.9 units on a scale
Standard Deviation 13.11
|
—
|
—
|
—
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—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 19, Day 1
|
-0.0 units on a scale
Standard Deviation 11.55
|
—
|
—
|
—
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—
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—
|
—
|
|
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 21, Day 1
|
-13.3 units on a scale
Standard Deviation 28.28
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 25, Day 1
|
6.7 units on a scale
|
—
|
—
|
—
|
—
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—
|
—
|
|
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Final visit
|
-5.0 units on a scale
Standard Deviation 19.40
|
—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visitPopulation: Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=16 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 11, Day 1
|
0.0 units on a scale
Standard Deviation 11.79
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 13, Day 1
|
-6.0 units on a scale
Standard Deviation 6.30
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 3, Day 1
|
-5.2 units on a scale
Standard Deviation 25.44
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 5, Day 1
|
6.7 units on a scale
Standard Deviation 5.27
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 7, Day 1
|
3.1 units on a scale
Standard Deviation 7.63
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 9, Day 1
|
8.3 units on a scale
Standard Deviation 11.79
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 15, Day 1
|
4.8 units on a scale
Standard Deviation 8.13
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 17, Day 1
|
-1.4 units on a scale
Standard Deviation 12.27
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 19, Day 1
|
-19.4 units on a scale
Standard Deviation 4.81
|
—
|
—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 21, Day 1
|
-33.3 units on a scale
Standard Deviation 23.57
|
—
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—
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—
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—
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—
|
—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 23, Day 1
|
-8.3 units on a scale
Standard Deviation 0.00
|
—
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—
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—
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—
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—
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—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Cycle 25, Day 1
|
-8.3 units on a scale
|
—
|
—
|
—
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—
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—
|
—
|
|
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Final visit
|
-11.5 units on a scale
Standard Deviation 23.55
|
—
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—
|
—
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—
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—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visitPopulation: Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The \[PROMIS\] Cancer Fatigue Short Form \[SF\] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Phase 1: Venetoclax 300 mg
n=16 Participants
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 3, Day 1
|
0.6 T-score
Standard Deviation 5.88
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 5, Day 1
|
-2.9 T-score
Standard Deviation 5.30
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 7, Day 1
|
-1.8 T-score
Standard Deviation 4.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 9, Day 1
|
-1.6 T-score
Standard Deviation 4.85
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 11, Day 1
|
0.1 T-score
Standard Deviation 7.24
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 13, Day 1
|
1.0 T-score
Standard Deviation 4.54
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 15, Day 1
|
-3.4 T-score
Standard Deviation 5.69
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 17, Day 1
|
0.6 T-score
Standard Deviation 7.36
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 19, Day 1
|
6.6 T-score
Standard Deviation 2.25
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 21, Day 1
|
11.6 T-score
Standard Deviation 6.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 23, Day 1
|
6.0 T-score
Standard Deviation 0.57
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Cycle 25, Day 1
|
5.6 T-score
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Final visit
|
1.4 T-score
Standard Deviation 6.51
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Venetoclax 300 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1: Venetoclax 600 mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Phase 1: Venetoclax 900 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1: Venetoclax 1200 mg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 1 Safety Expansion: Venetoclax 1200 mg
Serious events: 15 serious events
Other events: 35 other events
Deaths: 6 deaths
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Serious events: 6 serious events
Other events: 19 other events
Deaths: 1 deaths
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Serious events: 16 serious events
Other events: 27 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Phase 1: Venetoclax 300 mg
n=6 participants at risk
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=9 participants at risk
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=6 participants at risk
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=9 participants at risk
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=36 participants at risk
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=20 participants at risk
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=31 participants at risk
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
HYPERVISCOSITY SYNDROME
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
CHEST PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
PYREXIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
ABSCESS BACTERIAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
ENTEROBACTER SEPSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
ENTEROVIRUS INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
LISTERIA SEPSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
6/36 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PNEUMONIA ASPIRATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PNEUMONIA KLEBSIELLA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC MYELOMONOCYTIC LEUKAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
Other adverse events
| Measure |
Phase 1: Venetoclax 300 mg
n=6 participants at risk
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 600 mg
n=9 participants at risk
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 900 mg
n=6 participants at risk
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1: Venetoclax 1200 mg
n=9 participants at risk
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Safety Expansion: Venetoclax 1200 mg
n=36 participants at risk
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
|
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=20 participants at risk
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
n=31 participants at risk
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
3/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
3/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.6%
7/31 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
2/6 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
44.4%
4/9 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Eye disorders
CATARACT
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Eye disorders
EYE DISCHARGE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
DIARRHOEA
|
33.3%
2/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
44.4%
4/9 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
2/6 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
55.6%
5/9 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
36.1%
13/36 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
35.0%
7/20 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
38.7%
12/31 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
66.7%
6/9 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
50.0%
3/6 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
55.6%
5/9 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
50.0%
18/36 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
5/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
32.3%
10/31 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
STOMATITIS
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
TRICHOGLOSSIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
44.4%
4/9 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
2/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.1%
5/31 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
ASTHENIA
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
CHILLS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
FATIGUE
|
33.3%
2/6 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
41.7%
15/36 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
29.0%
9/31 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
FEELING COLD
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
MALAISE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
OEDEMA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
20.0%
4/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
PAIN
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
General disorders
PYREXIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
20.0%
4/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
PNEUMONIA
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
8/36 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
30.0%
6/20 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
DENTAL RESTORATION FAILURE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Injury, poisoning and procedural complications
TONGUE INJURY
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME ABNORMAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
20.0%
4/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
20.0%
4/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
CARDIAC MURMUR
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
9/36 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
20.0%
4/20 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
32.3%
10/31 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
3/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
12/36 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
3/9 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
30.6%
11/36 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
36.1%
13/36 • Number of events 21 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
5/20 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
3/9 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
30.0%
6/20 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
19.4%
6/31 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
6/36 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
9/36 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
20.0%
4/20 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
6/36 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
40.0%
8/20 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Metabolism and nutrition disorders
STEROID DIABETES
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
33.3%
2/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
6/36 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
5/20 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
3/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
19.4%
7/36 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC NEUROENDOCRINE TUMOUR
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
DIZZINESS
|
16.7%
1/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
50.0%
3/6 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
DYSAESTHESIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
HEAD DISCOMFORT
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
27.8%
10/36 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
HEMIPARESIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
HYPERSOMNIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
12.9%
4/31 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
40.0%
8/20 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
19.4%
6/31 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Psychiatric disorders
MOOD ALTERED
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
2/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
8/36 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
5/20 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.1%
5/31 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
33.3%
2/6 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
33.3%
2/6 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
13.9%
5/36 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
16.1%
5/31 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
5/20 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
25.0%
5/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
9.7%
3/31 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
8.3%
3/36 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
33.3%
2/6 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
4/36 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
SKIN ATROPHY
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
16.7%
1/6 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
3.2%
1/31 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/36 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.6%
2/36 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/31 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
15.0%
3/20 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
2.8%
1/36 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
6.5%
2/31 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER