Trial Outcomes & Findings for Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma (NCT NCT02490800)

NCT ID: NCT02490800

Last Updated: 2024-06-26

Results Overview

First 28-day treatment cycle dose limiting toxicities (DLT) graded according to Common Terminology Criteria for Adverse Events (CTCAE) in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

72 participants

Primary outcome timeframe

During first 28 day cycle

Results posted on

2024-06-26

Participant Flow

In the Phase 1 study, a total of 29 screening-failures occurred. Thus a total of 72 patients with advanced solid tumors, recurrent or progressive glioblastoma (GBM) or high-grade glioma (HGG) were enrolled in this Phase 1 and Phase 2a study.

Participant milestones

Participant milestones
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 2 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 4 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
The recommended Phase 2 dose (RP2D) of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Overall Study
STARTED
3
3
3
7
7
3
4
3
7
3
8
3
18
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
3
3
3
7
7
3
4
3
7
3
8
3
18

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 2 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 4 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
The recommended Phase 2 dose (RP2D) of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Overall Study
Adverse Event
0
0
0
2
3
2
0
0
0
0
0
2
2
Overall Study
Withdrawal by Subject
0
0
0
1
0
0
0
0
1
0
0
0
0
Overall Study
Progressive disease
3
3
3
4
4
1
4
3
6
2
7
1
10
Overall Study
Patient enrolled in post-trial access
0
0
0
0
0
0
0
0
0
1
1
0
6

Baseline Characteristics

Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 2 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 4 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=18 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily
Total
n=72 Participants
Total of all reporting groups
Age, Continuous
51.3 years
STANDARD_DEVIATION 21.94 • n=5 Participants
66.7 years
STANDARD_DEVIATION 10.50 • n=7 Participants
63.3 years
STANDARD_DEVIATION 6.51 • n=5 Participants
61.0 years
STANDARD_DEVIATION 16.55 • n=4 Participants
64.4 years
STANDARD_DEVIATION 7.00 • n=21 Participants
65.7 years
STANDARD_DEVIATION 12.06 • n=10 Participants
53.8 years
STANDARD_DEVIATION 9.95 • n=115 Participants
53.7 years
STANDARD_DEVIATION 7.77 • n=6 Participants
42.3 years
STANDARD_DEVIATION 9.62 • n=6 Participants
45.3 years
STANDARD_DEVIATION 11.50 • n=64 Participants
53.6 years
STANDARD_DEVIATION 9.78 • n=17 Participants
51.3 years
STANDARD_DEVIATION 16.74 • n=21 Participants
55.6 years
STANDARD_DEVIATION 10.43 • n=22 Participants
55.7 years
STANDARD_DEVIATION 12.52 • n=8 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
6 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
2 Participants
n=6 Participants
3 Participants
n=6 Participants
2 Participants
n=64 Participants
2 Participants
n=17 Participants
1 Participants
n=21 Participants
3 Participants
n=22 Participants
31 Participants
n=8 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=10 Participants
2 Participants
n=115 Participants
1 Participants
n=6 Participants
4 Participants
n=6 Participants
1 Participants
n=64 Participants
6 Participants
n=17 Participants
2 Participants
n=21 Participants
15 Participants
n=22 Participants
41 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
1 Participants
n=17 Participants
1 Participants
n=21 Participants
0 Participants
n=22 Participants
2 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
7 Participants
n=4 Participants
7 Participants
n=21 Participants
3 Participants
n=10 Participants
3 Participants
n=115 Participants
3 Participants
n=6 Participants
7 Participants
n=6 Participants
3 Participants
n=64 Participants
7 Participants
n=17 Participants
2 Participants
n=21 Participants
18 Participants
n=22 Participants
69 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=64 Participants
0 Participants
n=17 Participants
0 Participants
n=21 Participants
0 Participants
n=22 Participants
0 Participants
n=8 Participants

PRIMARY outcome

Timeframe: During first 28 day cycle

Population: MTD population: All patients from the safety set who met the following during the first 28-day treatment Cycle 1: * Received at least one dose of lisavanbulin and had experienced a DLT * Received at least 24 of the scheduled 28 doses for daily lisavanbulin administration, were not experiencing a DLT, had been observed for ≥ 28 days following the first dose, and had been evaluated for safety

First 28-day treatment cycle dose limiting toxicities (DLT) graded according to Common Terminology Criteria for Adverse Events (CTCAE) in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=23 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=24 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1: Maximum Tolerated Dose (MTD) of Daily Oral Lisavanbulin
16 mg
30 mg

PRIMARY outcome

Timeframe: Until the study discontinuation, on average 161 days (maximum of 381 days)

Population: The efficacy evaluable population (EEP) was the subset of the Full Analysis Population (FAP) who had at least one post baseline RANO assessment after having received at least 6 weeks of study treatment. For the primary endpoint, best objective response / objective response rate, the analysis was based on patients with measurable disease at baseline.

The best objective response was calculated as the proportion of patients responding (i.e., with a best observed objective response of complete or partial response) based on "radiological assessment in neuro-oncology (RANO)" criteria

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=9 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 2a: Best Objective Response
Complete response
0 Participants
Phase 2a: Best Objective Response
Partial response
1 Participants
Phase 2a: Best Objective Response
Stable disease
4 Participants
Phase 2a: Best Objective Response
Progressive disease
4 Participants

PRIMARY outcome

Timeframe: Until the study discontinuation, on average 161 days (maximum of 381 days)

Population: Number of patients in EEP with measurable disease at baseline

The ORR was calculated as the percentage of patients (rate) with complete and partial responses and its 95% Confidence Interval (CI) based on RANO criteria

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=9 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 2a: Objective Response Rate (ORR)
11.1 Percentage of participants
Interval 0.3 to 48.2

SECONDARY outcome

Timeframe: TEAEs were defined as all events occurring after lisavanbulin treatment began and up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)

Population: Safety population: All patients who received at least one full or partial dose of lisavanbulin and had at least one post-baseline safety assessment

Number of patients experiencing treatment-emergent adverse events (TEAE) of CTCAE Grade 3 or 4

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=18 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Number of Patients With CTCAE Grade 3-4 TEAEs
Number of patients with related TEAEs of Grade 3-4
0 Participants
0 Participants
1 Participants
2 Participants
4 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
3 Participants
Number of Patients With CTCAE Grade 3-4 TEAEs
Number of patients without TEAEs of Grade 3-4
3 Participants
2 Participants
2 Participants
2 Participants
2 Participants
1 Participants
3 Participants
3 Participants
6 Participants
2 Participants
4 Participants
2 Participants
10 Participants
Number of Patients With CTCAE Grade 3-4 TEAEs
Number of patients with only unrelated TEAEs of Grade 3-4
0 Participants
1 Participants
0 Participants
3 Participants
1 Participants
0 Participants
1 Participants
0 Participants
1 Participants
1 Participants
4 Participants
0 Participants
5 Participants

SECONDARY outcome

Timeframe: Plasma PK profiles were obtained on Cycle 1, Day 1 and on Cycle 2, Day 1 (pre-dose and from 0 up to 24 h post-dose) for all patients in the Phase 1 study who received lisavanbulin. For Phase 2 a study, PK parameters were obtained only on Cycle 1, Day 1

Population: The PK analysis set includes all patients who received at least one partial or complete dose of study drug (for the Phase 1 on Day 1 of Cycles 1 and 2, and for the Phase 2a only on Day 1 of Cycle 1) and had at least one post-baseline PK assessment

Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of avanbulin Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862)

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=5 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=3 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=2 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=6 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=1 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=18 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Cmax of Avanbulin (BAL27862)
6.900 ng/mL
Geometric Coefficient of Variation 0.580
9.800 ng/mL
Geometric Coefficient of Variation 0.490
23.400 ng/mL
Geometric Coefficient of Variation 0.440
40.880 ng/mL
Geometric Coefficient of Variation 0.270
29.190 ng/mL
Geometric Coefficient of Variation 0.490
44.270 ng/mL
Geometric Coefficient of Variation 0.640
120.260 ng/mL
Geometric Coefficient of Variation 0.490
109.560 ng/mL
Geometric Coefficient of Variation 0.490
116.630 ng/mL
Geometric Coefficient of Variation 0.580
147.730 ng/mL
Geometric Coefficient of Variation 0.410
159.020 ng/mL
Geometric Coefficient of Variation 0.080
35.260 ng/mL
Geometric Coefficient of Variation 0.560
48.930 ng/mL
Geometric Coefficient of Variation 0.910
75.130 ng/mL
Geometric Coefficient of Variation 0.110
114.890 ng/mL
Geometric Coefficient of Variation 0.430
64.110 ng/mL
Geometric Coefficient of Variation 0.460
78.700 ng/mL
Geometric Coefficient of Variation 0.640
103.950 ng/mL
Geometric Coefficient of Variation 0.470
95.370 ng/mL
Geometric Coefficient of Variation 0.110
146.500 ng/mL
Geometric Coefficient of Variation 0.580
146.010 ng/mL
Geometric Coefficient of Variation 0.340
159.100 ng/mL
Geometric Coefficient of Variation 0.650
190.000 ng/mL
Geometric Coefficient of Variation NA
Not evaluable
98.210 ng/mL
Geometric Coefficient of Variation 0.410

SECONDARY outcome

Timeframe: Plasma PK profiles were obtained on Cycle 1, Day 1 and on Cycle 2, Day 1 (pre-dose and from 0 up to 24 h post-dose) for all patients in the Phase 1 study who received lisavanbulin. For Phase 2 a study, PK parameters were obtained only on Cycle 1, Day 1

Population: The PK analysis set includes all patients who received at least one partial or complete dose of study drug (for the Phase 1 on Day 1 of Cycles 1 and 2, and for the Phase 2a only on Day 1 of Cycle 1) and had at least one post-baseline PK assessment

Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of avanbulin (BAL27862) Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=5 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=3 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=2 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=6 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=1 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=18 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Tmax of Avanbulin (BAL27862)
2.0 Hours
Interval 1.1 to 3.0
1.2 Hours
Interval 1.0 to 2.0
1.1 Hours
Interval 1.0 to 2.0
1.1 Hours
Interval 1.0 to 2.0
3.0 Hours
Interval 1.0 to 4.1
2.0 Hours
Interval 1.1 to 4.0
1.1 Hours
Interval 1.0 to 2.2
1.2 Hours
Interval 1.0 to 2.2
1.0 Hours
Interval 1.0 to 2.1
1.1 Hours
Interval 1.0 to 2.1
2.0 Hours
Interval 1.1 to 3.0
1.5 Hours
Interval 1.0 to 2.2
1.0 Hours
Interval 1.0 to 1.1
1.1 Hours
Interval 0.8 to 2.0
1.1 Hours
Interval 1.0 to 2.1
1.2 Hours
Interval 0.6 to 2.2
1.1 Hours
Interval 1.0 to 2.1
1.0 Hours
Interval 1.0 to 2.0
2.0 Hours
Interval 2.0 to 2.0
2.0 Hours
Interval 0.5 to 3.0
2.0 Hours
Interval 1.0 to 2.2
2.2 Hours
Interval 2.1 to 3.1
1.0 Hours
Interval 1.0 to 1.0
2.0 Hours
Interval 0.6 to 3.0

SECONDARY outcome

Timeframe: Plasma PK profiles were obtained on Cycle 1, Day 1 and on Cycle 2, Day 1 (pre-dose and from 0 up to 24 h post-dose) for all patients in the Phase 1 study who received lisavanbulin. For Phase 2 a study, PK parameters were obtained only on Cycle 1, Day 1

Population: The PK analysis set includes all patients who received at least one partial or complete dose of study drug (for the Phase 1 on Day 1 of Cycles 1 and 2, and for the Phase 2a only on Day 1 of Cycle 1) and had at least one post-baseline PK assessment

Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC of avanbulin (BAL27862) Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=5 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=3 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=2 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=6 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=1 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=18 Participants
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
AUC of Avanbulin (BAL27862)
34.040 h*ng/mL
Geometric Coefficient of Variation 0.840
74.020 h*ng/mL
Geometric Coefficient of Variation 0.830
180.060 h*ng/mL
Geometric Coefficient of Variation 0.150
356.490 h*ng/mL
Geometric Coefficient of Variation 0.160
258.460 h*ng/mL
Geometric Coefficient of Variation 0.320
439.660 h*ng/mL
Geometric Coefficient of Variation 0.620
823.980 h*ng/mL
Geometric Coefficient of Variation 0.350
896.420 h*ng/mL
Geometric Coefficient of Variation 0.540
1014.130 h*ng/mL
Geometric Coefficient of Variation 0.650
1265.130 h*ng/mL
Geometric Coefficient of Variation 0.410
1649.350 h*ng/mL
Geometric Coefficient of Variation 0.250
230.800 h*ng/mL
Geometric Coefficient of Variation 0.800
331.800 h*ng/mL
Geometric Coefficient of Variation 1.760
692.230 h*ng/mL
Geometric Coefficient of Variation 0.160
814.930 h*ng/mL
Geometric Coefficient of Variation 0.460
344.540 h*ng/mL
Geometric Coefficient of Variation 0.580
507.360 h*ng/mL
Geometric Coefficient of Variation 0.740
575.060 h*ng/mL
Geometric Coefficient of Variation 0.440
790.340 h*ng/mL
Geometric Coefficient of Variation 0.110
1055.130 h*ng/mL
Geometric Coefficient of Variation 0.250
1296.470 h*ng/mL
Geometric Coefficient of Variation 0.370
1264.610 h*ng/mL
Geometric Coefficient of Variation 0.320
1146.110 h*ng/mL
Geometric Coefficient of Variation NA
Not evaluable
713.710 h*ng/mL
Geometric Coefficient of Variation 0.480

SECONDARY outcome

Timeframe: Until the end of treatment, on average 151 days (maximum of 1653 days), every other 28 day cycle

Population: Full analysis population (FAP): All patients who received at least one partial or complete dose of study drug, based on the intent-to-treat (ITT) principle

The best objective response was calculated as the proportion of patients responding (i.e., with a best observed objective response of complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 for patients with advanced or recurrent solid tumors); and based on RANO criteria for patients with recurrent or progressive GBM / HGG

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1: Best Objective Response
Complete response
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Phase 1: Best Objective Response
Partial response
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Phase 1: Best Objective Response
Stable disease
1 Participants
0 Participants
1 Participants
4 Participants
3 Participants
1 Participants
0 Participants
1 Participants
2 Participants
1 Participants
1 Participants
2 Participants
Phase 1: Best Objective Response
Progressive disease
2 Participants
3 Participants
2 Participants
2 Participants
4 Participants
2 Participants
4 Participants
2 Participants
5 Participants
1 Participants
5 Participants
1 Participants
Phase 1: Best Objective Response
Missing
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Until the study discontinuation, on average 151 days (maximum 1653 days), every other 28 day cycle

Population: FAP (Phase 1 portion of the study)

The ORR was calculated as the percentage of patients (rate) with complete and partial responses and its 95% CI based on RECIST criteria v1.1 for patients with advanced or recurrent solid tumors; and based on RANO criteria for patients with recurrent or progressive GBM / HGG

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=4 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1: Objective Response Rate (ORR)
0 Percentage of patients
Interval 0.0 to 70.8
0 Percentage of patients
Interval 0.0 to 70.8
0 Percentage of patients
Interval 0.0 to 70.8
0 Percentage of patients
Interval 0.0 to 41.0
0 Percentage of patients
Interval 0.0 to 41.0
0 Percentage of patients
Interval 0.0 to 70.8
0 Percentage of patients
Interval 0.0 to 60.2
0 Percentage of patients
Interval 0.0 to 70.8
0 Percentage of patients
Interval 0.0 to 41.0
33.3 Percentage of patients
Interval 0.8 to 90.6
12.5 Percentage of patients
Interval 0.3 to 52.7
0 Percentage of patients
Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: 1 year

Population: PFS was summarized for the FAP and EEP

PFS was defined as the interval between the date of drug administration and the earliest date of objective disease progression based on RANO criteria for patients with recurrent or progressive GBM / HGG. Patients who have not progressed or died at the end of the study were censored at the time of their latest objective tumor assessment.

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=18 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=13 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 2a: PFS
2.5 Months
Interval 1.4 to 7.5
3.5 Months
Interval 1.6 to
Value(s) could not be evaluable due insufficient number of participants with events

SECONDARY outcome

Timeframe: 6 months

Population: FAP and EEP

Percentage of patients without disease progression based on RANO criteria 6 months after the start of treatment. The values were determined using the Kaplan-Meier and Brookmeyer-Crowley methods.

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=18 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=13 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 2a: PFS at 6 Months
31.3 Percentage of participants
Interval 11.8 to 53.1
43.3 Percentage of participants
Interval 16.3 to 67.9

SECONDARY outcome

Timeframe: 1 year

Population: FAP and EEP

Percentage of patients alive 12 months after the start of treatment. The values were determined using the Kaplan-Meier and Brookmeyer-Crowley methods.

Outcome measures

Outcome measures
Measure
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin
n=18 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 30 mg/day
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin
n=13 Participants
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 8 to 35 mg/day
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 16 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 1, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Cycle 2, Day 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Cycle 1, Day 1 Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
RP2D of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 2a: Overall Survival (OS) at 12 Months
42.9 percentage of patients
Interval 15.9 to 67.8
55.6 percentage of patients
Interval 20.4 to 80.5

Adverse Events

Phase 1 Patients Solid Tumors: Lisavanbulin 2 mg/Day

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 1 Patients With Solid Tumors: Lisavanbulin 4 mg/Day

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 1 Patients With Solid Tumors: Lisavanbulin 8 mg/Day

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 1 Patients With Solid Tumors: Lisavanbulin 16 mg/Day

Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths

Phase 1 Patients With Solid Tumors: Lisavanbulin 20 mg/Day

Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths

Phase 1 Patients With Solid Tumors: Lisavanbulin 30 mg/Day

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day

Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths

Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day

Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths

Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day

Serious events: 8 serious events
Other events: 18 other events
Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure
Phase 1 Patients Solid Tumors: Lisavanbulin 2 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 4 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 8 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 16 mg/Day
n=7 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 20 mg/Day
n=7 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 30 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=4 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=18 participants at risk
The recommended Phase 2 dose (RP2D) of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily
Investigations
Alanine aminotransferase increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Aspartate aminotransferase increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Troponin I increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Ataxia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Cognitive disorder
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Dysarthria
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Headache
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Ischaemic stroke
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Partial seizures
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Seizure
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Somnolence
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Thalamic infarction
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Abdominal pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Constipation
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Haematemesis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Nausea
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Vomiting
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Urinary incontinence
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Urinary retention
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Sepsis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Urinary tract infection
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Accidental overdose
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Fall
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Femoral neck fracture
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Fractured coccyx
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Stoma prolapse
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Disease progression
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Fatigue
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Gait disturbance
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
General physical health deterioration
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Peripheral swelling
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Pyrexia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Hepatobiliary disorders
Cholangitis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Confusional state
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Delirium
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Hallucination
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Hallucination, visual
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)

Other adverse events

Other adverse events
Measure
Phase 1 Patients Solid Tumors: Lisavanbulin 2 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 4 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 8 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 16 mg/Day
n=7 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 20 mg/Day
n=7 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Solid Tumors: Lisavanbulin 30 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 8 mg/Day
n=4 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 15 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 20 mg/Day
n=7 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 25 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 30 mg/Day
n=8 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 1 Patients With Recurrent or Progressive GBM / HGG: Lisavanbulin 35 mg/Day
n=3 participants at risk
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
Phase 2a Patients With Recurrent GBM: Lisavanbulin 25 mg/Day
n=18 participants at risk
The recommended Phase 2 dose (RP2D) of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily
Investigations
Blood alkaline phosphatase increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Blood bilirubin increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Blood creatine phosphokinase decreased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Blood creatine phosphokinase increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Blood creatinine increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Blood glucose increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Electrocardiogram abnormal
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Gamma-glutamyltransferase increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Lipase increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Lymphocyte count decreased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Neutrophil count decreased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Neutrophil count increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Troponin T increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Troponin increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Weight decreased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
White blood cell count decreased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
White blood cell count increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Alanine aminotransferase increased
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
37.5%
3/8 • Number of events 5 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
22.2%
4/18 • Number of events 5 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Investigations
Aspartate aminotransferase increased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
2/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Myocardial ischaemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Palpitations
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Sinus bradycardia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Sinus tachycardia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Tachycardia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Ventricular arrhythmia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Cardiac disorders
Ventricular extrasystoles
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Blood and lymphatic system disorders
Anaemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Blood and lymphatic system disorders
Neutropenia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Blood and lymphatic system disorders
Neutrophilia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Amnesia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Aphasia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Balance disorder
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Brain oedema
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Cognitive disorder
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Coordination abnormal
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Disturbance in attention
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Dizziness
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Dysarthria
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Facial paralysis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Headache
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Hemianopia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Hemiparesis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
22.2%
4/18 • Number of events 4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Hyporesponsive to stimuli
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Lethargy
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Memory impairment
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Meralgia paraesthetica
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Migraine
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Neuralgia
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Neurologic neglect syndrome
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Neuropathy peripheral
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Paraesthesia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Partial seizures
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Peroneal nerve palsy
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Restless legs syndrome
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Sciatica
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Seizure
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 6 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 6 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Sensory loss
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Nervous system disorders
Tremor
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
2/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Eye disorders
Blepharitis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Eye disorders
Cataract
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Eye disorders
Cataract subcapsular
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Eye disorders
Eye pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Eye disorders
Visual impairment
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Eye disorders
Vitreous floaters
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Ear and labyrinth disorders
Ear pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Ear and labyrinth disorders
Otorrhoea
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Ear and labyrinth disorders
Tinnitus
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Ear and labyrinth disorders
Vertigo
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Epistaxis
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Abdominal pain
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Abdominal pain lower
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Anal incontinence
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Constipation
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Defaecation urgency
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Diarrhoea
33.3%
1/3 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 5 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Dry mouth
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Epigastric discomfort
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Intestinal fistula
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Lip dry
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Mouth ulceration
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Nausea
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Oral pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Rectal perforation
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Stomatitis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Gastrointestinal disorders
Vomiting
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Bladder discomfort
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Calculus urinary
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Haematuria
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Micturition urgency
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Nephrolithiasis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Nocturia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Pollakiuria
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Polyuria
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Renal colic
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Renal and urinary disorders
Urinary incontinence
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Cold sweat
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Hair colour changes
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Hair growth abnormal
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Pruritus
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Rash
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Skin disorder
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Skin and subcutaneous tissue disorders
Xeroderma
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Back pain
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Limb discomfort
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Musculoskeletal and connective tissue disorders
Sacral pain
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
28.6%
2/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 6 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Hypophagia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Vitamin B12 deficiency
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Metabolism and nutrition disorders
Vitamin D deficiency
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
COVID-19
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
22.2%
4/18 • Number of events 4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Candida infection
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Cystitis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Escherichia urinary tract infection
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Fungal infection
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Gastroenteritis viral
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Hordeolum
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Lip infection
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Lower respiratory tract infection
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Nasopharyngitis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Oral candidiasis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Oral herpes
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Rhinitis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Skin infection
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Upper respiratory tract infection
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Urinary tract infection
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Infections and infestations
Viral infection
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Contusion
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Fall
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
75.0%
3/4 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Vascular disorders
Hot flush
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Vascular disorders
Hypertension
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Vascular disorders
Hypotension
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Chills
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Early satiety
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Fatigue
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
42.9%
3/7 • Number of events 4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
66.7%
2/3 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
44.4%
8/18 • Number of events 10 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Gait disturbance
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
16.7%
3/18 • Number of events 3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
General physical health deterioration
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Localised oedema
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Oedema peripheral
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Pyrexia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
General disorders
Unevaluable event
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Hepatobiliary disorders
Hepatic cyst
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Hepatobiliary disorders
Hyperbilirubinaemia
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Reproductive system and breast disorders
Acquired phimosis
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Reproductive system and breast disorders
Erectile dysfunction
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Agitation
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Anxiety
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Confusional state
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
11.1%
2/18 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Depressed mood
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Depression
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Disorientation
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Hallucination
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Hallucination, visual
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Insomnia
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
14.3%
1/7 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
1/4 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
25.0%
2/8 • Number of events 2 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
1/3 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
33.3%
6/18 • Number of events 6 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Libido decreased
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
12.5%
1/8 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/18 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Psychomotor retardation
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
Psychiatric disorders
Somnambulism
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/4 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/7 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/8 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
0.00%
0/3 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
5.6%
1/18 • Number of events 1 • Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)

Additional Information

Thomas Kaindl, MD

Basilea Pharmaceutica International Ltd, Allschwil

Phone: +41 61 567 15 24

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60