Phase 1/2a Study of Oral BAL101553 in Adult Patients With... | NCT02490800 | Trialant
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Studies Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma NCT02490800 Show options Lisavanbulin Phase 1 dose escalation portion Lisavanbulin Phase 2a expansion portion Belgium Germany Switzerland United Kingdom Obsolete or Duplicate NCT IDs Not provided
Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma
An Open-label Phase 1/2a Study of Oral BAL101553 in Adult Patients With Advanced Solid Tumors and in Adult Patients With Recurrent or Progressive Glioblastoma or High-grade Glioma
Basilea Pharmaceutica INDUSTRY
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Jul 2, 2015
Results First Submitted Date Sep 29, 2023
Results First Submitted that Met QC Criteria Jun 25, 2024
Results First Posted Date Jun 26, 2024 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Jun 25, 2024
Responsible Party, by Official Title Sponsor
Basilea Pharmaceutica INDUSTRY
Has Data Monitoring Committee (DMC) No
Pediatric Postmarket Surveillance of a Device Product Not provided
First in human, open-label, dose escalation (Phase I) and expansion study (Phase 2a) of oral lisavanbulin (BAL101553) in adult patients with advanced solid tumors and adult patients with recurrent or progressive glioblastoma (GBM) or high-grade glioma (HGG).
This was the first study of the oral formulation (hard capsules) of lisavanbulin. Lisavanbulin was administered once daily during each day of a 28-day treatment cycle to adults with advanced or recurrent solid tumors or recurrent or progressive GBM / HGG who had failed standard therapy, or for whom no effective standard therapy was available.
In Phase 1, the highest dose of lisavanbulin was determined that could safely be given to adults with advanced or recurrent solid tumors, recurrent or progressive GBM / HGG.
In Phase 2a, the tolerability and potential anticancer activity of oral lisavanbulin was assessed in patients with recurrent GBM whose tumor tissue tests positive for end-binding protein 1 (EB1). The study also measured pharmacokinetics.
Advanced solid tumors Recurrent glioblastoma High-grade glioma Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Phase 1 dose escalation portion Experimental Phase 1 dose escalation portion - an accelerated 3+3 titration design in patients with:
advanced or recurrent solid tumors
recurrent or progressive GBM / HGG
Drug: Lisavanbulin Phase 1 dose escalation portion Phase 2a dose expansion portion Experimental Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
Drug: Lisavanbulin Phase 2a expansion portion
Name Type Description Arm Group Labels Other Names Lisavanbulin Phase 1 dose escalation portion Drug 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 35 mg/day
Measure Description Time Frame Phase 1: Maximum Tolerated Dose (MTD) of Daily Oral Lisavanbulin 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
During first 28 day cycle Phase 2a: Best Objective Response 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
Until the study discontinuation, on average 161 days (maximum of 381 days) Phase 2a: Objective Response Rate (ORR) 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
Until the study discontinuation, on average 161 days (maximum of 381 days)
Measure Description Time Frame Number of Patients With CTCAE Grade 3-4 TEAEs Number of patients experiencing treatment-emergent adverse events (TEAE) of CTCAE Grade 3 or 4
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)
Main Inclusion Criteria:
Age ≥ 18 years
Patients who had in the Phase 1 portion either of the following:
a histologically- or cytologically confirmed advanced or recurrent solid tumor, who failed standard therapy, or for whom no effective standard therapy was available to them
histologically-confirmed GBM or HGG, with progressive or recurrent disease after prior radiotherapy, with or without chemotherapy. This also included patients with histologically-confirmed low-grade glioma who presented with unequivocal evidence by imaging of transformation to GBM / HGG
Phase 2a dose expansion portion:
Recurrent, histologically confirmed, glioblastoma with tumor tissue positive for EB1; eligible patients with de novo glioblastoma after prior radical chemo-radiotherapy or secondary glioblastoma after prior chemotherapy or radiotherapy.
Phase 1: Patients had to have measurable disease; according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 for patients with advanced or recurrent solid tumors, and per radiological assessment in neuro-oncology (RANO) criteria for patients with recurrent or progressive GBM /HGG. Phase 2a: Patients had to be evaluable per RANO criteria.
Life expectancy ≥ 12 weeks
Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
Patients with advanced solid tumors had to have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and patients with recurrent or progressive glioblastoma had to have an ECOG performance status ≤ 2
Main Exclusion Criteria:
Patients with advanced or recurrent solid tumors who had received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks (2 weeks for single fraction of palliative radiotherapy, 6 weeks for nitrosoureas or mitomycin C) prior to starting study drug or who had not recovered from side effects of prior therapies
Patients with recurrent or progressive GBM / HGG who had: received radiotherapy within 6 weeks (Phase 1) or 12 weeks (Phase 2a), unless there was a new area of enhancement consistent with recurrent tumor outside the radiation field; received administration of prior anti-tumor chemotherapy within 4 weeks, or within 6 weeks for nitrosoureas; undergone surgical resection within 4 weeks (Phase 2a: 2 weeks) or a stereotactic biopsy/core biopsy within 1 week prior to starting study drug;
Patients who have had prior exposure to lisavanbulin
Inability to swallow oral medication
Increase in steroid dose in GBM or HGG patients within 5 days prior to first study-drug administration or requirement for > 6 mg/day dexamethasone or equivalent for symptom control.
Patients with gastrointestinal disease or those who have had a procedure that was expected to interfere with the oral absorption or tolerance of lisavanbulin
Symptomatic brain metastases or leptomeningeal disease, which was indicative of active disease, in patients with advanced or recurrent solid tumors.
Peripheral neuropathy ≥ CTCAE grade 2.
Uncontrolled intercurrent illness that would have unduly increased the risk of toxicity or limit compliance with study requirements
Systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at the screening visit.
Blood pressure (BP) combination treatment with more than two antihypertensive medications.
Women who were pregnant or breast-feeding. Men or women of reproductive potential who were not willing to apply effective birth control
Accepts Healthy Volunteers No
Name Affiliation Role Thomas Kaindl, MD Basilea Pharmaceutica International Ltd, Allschwil Study Director
Facility Status City State ZIP Country Contacts UZ Leuven Leuven 3000 Belgium Klinikum der Goethe-Universität Frankfurt
PubMed Identifier Type Citation Retractions Derived Lopez JS, Haefliger S, Plummer R, Clement PM, Jeffry Evans TR, Laubli H, Roth P, Kristeleit R, Brazil L, Tabatabai G, Wick A, Wunderlich B, Beebe K, Eisner JR, Lane H, Engelhardt M, Kaindl T, Hau P, Hundsberger T, Steinbach J. A phase 1/2a dose-finding study and biomarker assessment of oral lisavanbulin in patients with high-grade glioma or glioblastoma. Cell Rep Med. 2025 Jun 17;6(6):102165. doi: 10.1016/j.xcrm.2025.102165.
Available IPD Information Not provided
No data available
No data is available for this block.
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.
ID Title Description FG000 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
FG001 Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 4 mg/Day
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description Not provided
No data available
No data is available for this block.
Document Has No Statistical Analysis Plan (SAP) Not provided
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot Yes No No Study Protocol Jul 1, 2021 Sep 26, 2023
No data available
No data is available for this block.
Randomized
Intervention Model Description Not provided
Phase 1 dose escalation portion Lisavanbulin Phase 2a expansion portion Drug Recommended Phase 2 dose (RP2D) of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Phase 2a dose expansion portion
Cmax of Avanbulin (BAL27862)
Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of avanbulin Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862)
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
Tmax of Avanbulin (BAL27862) Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of avanbulin (BAL27862) Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
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
AUC of Avanbulin (BAL27862) Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC of avanbulin (BAL27862) Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
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
Phase 1: Best Objective Response 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
Until the end of treatment, on average 151 days (maximum of 1653 days), every other 28 day cycle
Phase 1: Objective Response Rate (ORR) 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
Until the study discontinuation, on average 151 days (maximum 1653 days), every other 28 day cycle
Phase 2a: PFS 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.
1 year
Phase 2a: PFS at 6 Months 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.
6 months
Phase 2a: Overall Survival (OS) at 12 Months Percentage of patients alive 12 months after the start of treatment. The values were determined using the Kaplan-Meier and Brookmeyer-Crowley methods.
1 year
Universitätsklinikum Heidelberg Heidelberg 69120 Germany
Universitätsklinikum Regensburg Regensburg 93053 Germany
Universitätsklinikum Tübingen Tübingen 72076 Germany
Universitätsspital Basel Basel 4031 Switzerland
Inselspital Universitätsspital Bern Bern 3010 Switzerland
Kantonsspital St. Gallen Sankt Gallen 9007 Switzerland
Universitätsspital Zürich Zurich 8091 Switzerland
Beatson West of Scotland Cancer Centre Glasgow G12 0YN United Kingdom
University College London NHS Foundation Trust London NW1 2BU United Kingdom
Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care Newcastle upon Tyne NE7 7DN United Kingdom
Royal Marsden Hospital Sutton SM2 5PT United Kingdom
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
FG002 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
FG003 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
FG004 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
FG005 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
FG006 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
FG007 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
FG008 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
FG009 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
FG010 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
FG011 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
FG012 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.
FG000 3 subjects
FG001 3 subjects
FG002 3 subjects
FG003 7 subjects
FG004 7 subjects
FG005 3 subjects
FG006 4 subjects
FG007 3 subjects
FG008 7 subjects
FG009 3 subjects
FG010 8 subjects
FG011 3 subjects
FG012 18 subjects COMPLETED FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 0 subjects FG005 0 subjects FG006 0 subjects FG007 0 subjects FG008 0 subjects FG009 0 subjects FG010 0 subjects FG011 0 subjects FG012 0 subjects
NOT COMPLETED FG000 3 subjects FG001 3 subjects FG002 3 subjects FG003 7 subjects FG004 7 subjects FG005 3 subjects FG006 4 subjects FG007 3 subjects FG008 7 subjects FG009 3 subjects FG010 8 subjects FG011 3 subjects FG012 18 subjects
Type Comment Reasons Adverse Event FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 2 subjects FG004 3 subjects FG005 2 subjects FG006 0 subjects FG007 0 subjects FG008 0 subjects FG009 0 subjects FG010 0 subjects FG011 2 subjects FG012 2 subjects Withdrawal by Subject FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 1 subjects FG004 Progressive disease FG000 3 subjects FG001 3 subjects FG002 3 subjects FG003 4 subjects FG004 Patient enrolled in post-trial access FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004
Type of Units Analyzed
ID Title Description BG000 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
BG001 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
BG002 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
BG003 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
BG004 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
BG005 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
BG006 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
BG007 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
BG008 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
BG009 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
BG010 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
BG011 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
BG012 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
BG013 Total Total of all reporting groups
Units Counts Participants BG000 3 BG001 3 BG002 3 BG003 7 BG004 7 BG005 3 BG006 4 BG007 3 BG008 7 BG009 3 BG010 8 BG011 3 BG012 18 BG013 72
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Continuous Mean Standard Deviation years Title Denominators Categories Title Measurements BG000 51.3 ± 21.94 BG001 66.7 ± 10.50 BG002 63.3 ± 6.51 BG003
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Race (NIH/OMB) Count of Participants Participants Title Denominators Categories Title Measurements American Indian or Alaska Native
Type Title Description Population Description Reporting Status Anticipated Posting Date Parameter Type Dispersion Type Unit of Measure Calculate Percentage Time Frame Units Analyzed Denominator Units Selected Arm/Group Information Denominators Classes Analyses Primary Phase 1: Maximum Tolerated Dose (MTD) of Daily Oral Lisavanbulin 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
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
Posted Number mg During first 28 day cycle ID Title Description OG000 Phase 1 Patients With Advanced or Recurrent Solid Tumors: 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 2 to 30 mg/day
OG001 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
Title Denominators Categories
Primary Phase 2a: Best Objective Response 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
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.
Posted Count of Participants Participants Until the study discontinuation, on average 161 days (maximum of 381 days) ID Title Description OG000 Phase 2a Dose Expansion Portion Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and end-binding protein 1 (EB1)-positive GBM
BAL101553 Phase 2a expansion portion: RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Primary Phase 2a: Objective Response Rate (ORR) 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
Number of patients in EEP with measurable disease at baseline
Posted Number 95% Confidence Interval Percentage of participants Until the study discontinuation, on average 161 days (maximum of 381 days) ID Title Description OG000 Phase 2a Dose Expansion Portion Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
BAL101553 Phase 2a expansion portion: RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Secondary Number of Patients With CTCAE Grade 3-4 TEAEs Number of patients experiencing treatment-emergent adverse events (TEAE) of CTCAE Grade 3 or 4
Safety population: All patients who received at least one full or partial dose of lisavanbulin and had at least one post-baseline safety assessment
Posted Count of Participants Participants 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) ID Title Description OG000 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
OG001 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
OG002 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
Secondary Cmax of Avanbulin (BAL27862) Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of avanbulin Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862)
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
Posted Geometric Mean Geometric Coefficient of Variation ng/mL 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 ID Title Description OG000 Phase 1 Cycle 1, Day 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
OG001 Phase 1 Cycle 2, Day 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
OG002 Phase 1 Cycle 1, Day 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 4 mg/Day
Secondary Tmax of Avanbulin (BAL27862) Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of avanbulin (BAL27862) Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
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
Posted Median Full Range Hours 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 ID Title Description OG000 Phase 1 Cycle 1, Day 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
OG001 Phase 1 Cycle 2, Day 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
OG002 Phase 1 Cycle 1, Day 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 4 mg/Day
Secondary AUC of Avanbulin (BAL27862) Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC of avanbulin (BAL27862) Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
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
Posted Geometric Mean Geometric Coefficient of Variation h*ng/mL 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 ID Title Description OG000 Phase 1 Cycle 1, Day 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
OG001 Phase 1 Cycle 2, Day 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
OG002 Phase 1 Cycle 1, Day 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 4 mg/Day
Secondary Phase 1: Best Objective Response 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
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
Posted Count of Participants Participants Until the end of treatment, on average 151 days (maximum of 1653 days), every other 28 day cycle ID Title Description OG000 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
OG001 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
OG002 Phase 1 Patients With Advanced or Recurrent Solid Tumors: Lisavanbulin 8 mg/Day
Secondary Phase 1: Objective Response Rate (ORR) 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
FAP (Phase 1 portion of the study)
Posted Number 95% Confidence Interval Percentage of patients Until the study discontinuation, on average 151 days (maximum 1653 days), every other 28 day cycle ID Title Description OG000 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
OG001 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
OG002 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
Secondary Phase 2a: PFS 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.
PFS was summarized for the FAP and EEP
Posted Median 95% Confidence Interval Months 1 year ID Title Description OG000 Phase 2a Dose Expansion Portion (FAP) Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
OG001 Phase 2a Dose Expansion Portion (EEP) Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Secondary Phase 2a: PFS at 6 Months 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.
Posted Number 95% Confidence Interval Percentage of participants 6 months ID Title Description OG000 Phase 2a Dose Expansion Portion (FAP) Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
OG001 Phase 2a Dose Expansion Portion (EEP) Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Secondary Phase 2a: Overall Survival (OS) at 12 Months Percentage of patients alive 12 months after the start of treatment. The values were determined using the Kaplan-Meier and Brookmeyer-Crowley methods.
Posted Median 95% Confidence Interval percentage of patients 1 year ID Title Description OG000 Phase 2a Dose Expansion Portion (FAP) Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
BAL101553 Phase 2a expansion portion: RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
OG001 Phase 2a Dose Expansion Portion (EEP) Phase 2a expansion portion (Simon's two-stage design) - Patients with recurrent and EB1-positive GBM
BAL101553 Phase 2a expansion portion: RP2D dose of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.
Treatment-emergent events occurring after lisavanbulin treatment began, up to 28 days after last study drug administration which corresponded to a maximum of 1653 days (4,5 years)
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Phase 1 Patients 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
0 3 0 3 3 3 EG001 Phase 1 Patients With 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
0 3 2 3 3 3 EG002 Phase 1 Patients With 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
0 3 0 3 3 3 EG003 Phase 1 Patients With 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
0 7 4 7 6 7 EG004 Phase 1 Patients With 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
0 7 5 7 7 7 EG005 Phase 1 Patients With 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
0 3 1 3 3 3 EG006 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
0 4 0 4 4 4 EG007 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
0 3 0 3 3 3 EG008 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
1 7 2 7 5 7 EG009 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
0 3 1 3 3 3 EG010 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
1 8 4 8 7 8 EG011 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
0 3 2 3 3 3 EG012 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
7 18 8 18 18 18
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Alanine aminotransferase increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 7 at risk EG004 0 events 0 affected 7 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 4 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 7 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 8 at risk EG011 0 events 0 affected 3 at risk EG012 1 events 1 affected 18 at risk Aspartate aminotransferase increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Troponin I increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Atrial fibrillation Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Ataxia Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cognitive disorder Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dysarthria Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Headache Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Ischaemic stroke Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Partial seizures Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Seizure Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Somnolence Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Thalamic infarction Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Aspiration Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dyspnoea Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Abdominal pain Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Constipation Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Haematemesis Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Intestinal obstruction Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Nausea Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Vomiting Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Urinary incontinence Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Urinary retention Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Muscular weakness Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hyponatraemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Sepsis Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Urinary tract infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Accidental overdose Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Fall Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Femoral neck fracture Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Fractured coccyx Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Humerus fracture Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Stoma prolapse Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cholangiocarcinoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Intracranial tumour haemorrhage Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Disease progression General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Fatigue General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Gait disturbance General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 General physical health deterioration General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Pain General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Peripheral swelling General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Pyrexia General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cholangitis Hepatobiliary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Confusional state Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Delirium Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hallucination Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hallucination, visual Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Alanine aminotransferase increased Investigations MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 1 events 1 affected 7 at risk EG004 2 events 2 affected 7 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 4 at risk EG007 2 events 1 affected 3 at risk EG008 0 events 0 affected 7 at risk EG009 1 events 1 affected 3 at risk EG010 5 events 3 affected 8 at risk EG011 0 events 0 affected 3 at risk EG012 5 events 4 affected 18 at risk Aspartate aminotransferase increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Blood alkaline phosphatase increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Blood bilirubin increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Blood creatine phosphokinase decreased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Blood creatine phosphokinase increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Blood creatinine increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Blood glucose increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Electrocardiogram abnormal Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Gamma-glutamyltransferase increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Lipase increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Lymphocyte count decreased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neutrophil count decreased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neutrophil count increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Troponin T increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Troponin increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Weight decreased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 White blood cell count decreased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 White blood cell count increased Investigations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Myocardial ischaemia Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Palpitations Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Sinus bradycardia Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Sinus tachycardia Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Tachycardia Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Ventricular arrhythmia Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Ventricular extrasystoles Cardiac disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Anaemia Blood and lymphatic system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neutropenia Blood and lymphatic system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neutrophilia Blood and lymphatic system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Thrombocytopenia Blood and lymphatic system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Amnesia Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Aphasia Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Balance disorder Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Brain oedema Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cognitive disorder Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Coordination abnormal Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Disturbance in attention Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dizziness Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dysarthria Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Facial paralysis Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Headache Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 2 events 2 affected 3 at risk EG003 Hemianopia Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hemiparesis Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hyporesponsive to stimuli Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Lethargy Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 2 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Memory impairment Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Meralgia paraesthetica Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Migraine Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neuralgia Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neurologic neglect syndrome Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neuropathy peripheral Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Paraesthesia Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Partial seizures Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Peroneal nerve palsy Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Restless legs syndrome Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Sciatica Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Seizure Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Sensory loss Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Tremor Nervous system disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Blepharitis Eye disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cataract Eye disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cataract subcapsular Eye disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Eye pain Eye disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Visual impairment Eye disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Vitreous floaters Eye disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Ear pain Ear and labyrinth disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Otorrhoea Ear and labyrinth disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Tinnitus Ear and labyrinth disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Vertigo Ear and labyrinth disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Dyspnoea Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dyspnoea exertional Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Oropharyngeal pain Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Pleuritic pain Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Productive cough Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Rhinorrhoea Respiratory, thoracic and mediastinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 2 events 2 affected 3 at risk EG003 Abdominal discomfort Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Abdominal pain Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Abdominal pain lower Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Abdominal pain upper Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Anal incontinence Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Constipation Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 3 events 2 affected 3 at risk EG002 2 events 1 affected 3 at risk EG003 Defaecation urgency Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Diarrhoea Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 3 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 2 events 2 affected 3 at risk EG003 Dry mouth Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dysphagia Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Epigastric discomfort Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Gastrointestinal haemorrhage Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Gastrooesophageal reflux disease Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Intestinal fistula Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Lip dry Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Mouth ulceration Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Nausea Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Oral pain Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Rectal haemorrhage Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Rectal perforation Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Stomatitis Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Vomiting Gastrointestinal disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Bladder discomfort Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Calculus urinary Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Haematuria Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Micturition urgency Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Nephrolithiasis Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Nocturia Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Pollakiuria Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Polyuria Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Renal colic Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Urinary incontinence Renal and urinary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Alopecia Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cold sweat Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dry skin Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Hair colour changes Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hair growth abnormal Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Night sweats Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Palmar-plantar erythrodysaesthesia syndrome Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Petechiae Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Pruritus Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Rash Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Rash maculo-papular Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Skin disorder Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Skin ulcer Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Urticaria Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Xeroderma Skin and subcutaneous tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Arthralgia Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Back pain Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Joint swelling Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Limb discomfort Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Muscle spasms Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Muscular weakness Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Musculoskeletal chest pain Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Musculoskeletal discomfort Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Neck pain Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Pain in extremity Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Sacral pain Musculoskeletal and connective tissue disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Decreased appetite Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Dehydration Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hypercalcaemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hyperglycaemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hyperphosphataemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hypocalcaemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hypoglycaemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hypokalaemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hyponatraemia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hypophagia Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Vitamin B12 deficiency Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Vitamin D deficiency Metabolism and nutrition disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 COVID-19 Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Candida infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Cystitis Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Escherichia urinary tract infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Fungal infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Gastroenteritis viral Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hordeolum Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Lip infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Lower respiratory tract infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Nasopharyngitis Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Oral candidiasis Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Oral herpes Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Rhinitis Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Skin infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Upper respiratory tract infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Urinary tract infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Viral infection Infections and infestations MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Contusion Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Fall Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Procedural pain Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Skin laceration Injury, poisoning and procedural complications MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Benign neoplasm Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Haemangioma of liver Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Metastases to meninges Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Skin papilloma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Tumour pain Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Hot flush Vascular disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hypertension Vascular disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Hypotension Vascular disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Chills General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Early satiety General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Fatigue General disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Gait disturbance General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 General physical health deterioration General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Localised oedema General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Oedema peripheral General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Pyrexia General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Unevaluable event General disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hepatic cyst Hepatobiliary disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hyperbilirubinaemia Hepatobiliary disorders MedDRA 25.0 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Acquired phimosis Reproductive system and breast disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Erectile dysfunction Reproductive system and breast disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Vaginal haemorrhage Reproductive system and breast disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Agitation Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Anxiety Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Confusional state Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Depressed mood Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Depression Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Disorientation Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hallucination Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Hallucination, visual Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Insomnia Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 Libido decreased Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Psychomotor retardation Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 Somnambulism Psychiatric disorders MedDRA 25.0 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? Yes
Title Organization Phone Extension Email Thomas Kaindl, MD Basilea Pharmaceutica International Ltd, Allschwil +41 61 567 15 24 thomas.kaindl@basilea.com
SAP No Yes No Statistical Analysis Plan May 18, 2022 Sep 26, 2023
ID Term D009369 Neoplasms D005909 Glioblastoma D005910 Glioma
ID Term D001254 Astrocytoma D018302 Neoplasms, Neuroepithelial D017599 Neuroectodermal Tumors D009373 Neoplasms, Germ Cell and Embryonal D009370 Neoplasms by Histologic Type D009375 Neoplasms, Glandular and Epithelial D009380 Neoplasms, Nerve Tissue
ID Term C000599741 lisavanbulin
0 subjects
FG005 0 subjects
FG006 0 subjects
FG007 0 subjects
FG008 1 subjects
FG009 0 subjects
FG010 0 subjects
FG011 0 subjects
FG012 0 subjects 4 subjects
FG005 1 subjects
FG006 4 subjects
FG007 3 subjects
FG008 6 subjects
FG009 2 subjects
FG010 7 subjects
FG011 1 subjects
FG012 10 subjects 0 subjects
FG005 0 subjects
FG006 0 subjects
FG007 0 subjects
FG008 0 subjects
FG009 1 subjects
FG010 1 subjects
FG011 0 subjects
FG012 6 subjects 61.0
± 16.55
BG004 64.4 ± 7.00
BG005 65.7 ± 12.06
BG006 53.8 ± 9.95
BG007 53.7 ± 7.77
BG008 42.3 ± 9.62
BG009 45.3 ± 11.50
BG010 53.6 ± 9.78
BG011 51.3 ± 16.74
BG012 55.6 ± 10.43
BG013 55.7 ± 12.52 1
BG003 5
BG004 6
BG005 0
BG006 2
BG007 2
BG008 3
BG009 2
BG010 2
BG011 1
BG012 3
BG013 31 Male BG000 1 BG001 1 BG002 2 BG003 2 BG004 1 BG005 3 BG006 2 BG007 1 BG008 4 BG009 1 BG010 6 BG011 2 BG012 15 BG013 41
0
BG003 0
BG004 0
BG005 0
BG006 0
BG007 0
BG008 0
BG009 0
BG010 0
BG011 0
BG012 0
BG013 0 Asian BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 0 BG008 0 BG009 0 BG010 1 BG011 1 BG012 0 BG013 2
Native Hawaiian or Other Pacific Islander BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 0 BG008 0 BG009 0 BG010 0 BG011 0 BG012 0 BG013 0
Black or African American BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 1 BG007 0 BG008 0 BG009 0 BG010 0 BG011 0 BG012 0 BG013 1
White BG000 3 BG001 3 BG002 3 BG003 7 BG004 7 BG005 3 BG006 3 BG007 3 BG008 7 BG009 3 BG010 7 BG011 2 BG012 18 BG013 69
More than one race BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 0 BG008 0 BG009 0 BG010 0 BG011 0 BG012 0 BG013 0
Unknown or Not Reported BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 0 BG008 0 BG009 0 BG010 0 BG011 0 BG012 0 BG013 0
9
Title Denominators Categories Title Measurements Complete response Partial response Stable disease Progressive disease
9
Title Denominators Categories
OG003 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
OG004 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
OG005 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
OG006 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
OG007 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
OG008 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
OG009 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
OG010 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
OG011 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
OG012 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.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 7 OG004 7 OG005 3 OG006 4 OG007 3 OG008 7 OG009 3 OG010 8 OG011 3 OG012 18
Title Denominators Categories Number of patients with only unrelated TEAEs of Grade 3-4 Title Measurements OG000 0 OG001 1 OG002 0 OG003 3 OG004 1 OG005 0 OG006 1 OG007 0 OG008 1 OG009 1 OG010 4 OG011 0 OG012 5
Number of patients with related TEAEs of Grade 3-4 Number of patients without TEAEs of Grade 3-4
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
OG003 Phase 1 Cycle 2, Day 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
OG004 Phase 1 Cycle 1, Day 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
OG005 Phase 1 Cycle 2, Day 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
OG006 Phase 1 Cycle 1, Day 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
OG007 Phase 1 Cycle 2, Day 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
OG008 Phase 1 Cycle 1, Day 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
OG009 Phase 1 Cycle 2, Day 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
OG010 Phase 1 Cycle 1, Day 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
OG011 Phase 1 Cycle 1, Day 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
OG012 Phase 1 Cycle 2, Day 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
OG013 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
OG014 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
OG015 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
OG016 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
OG017 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
OG018 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
OG019 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
OG020 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
OG021 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
OG022 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
OG023 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.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 3 OG004 3 OG005 3 OG006 7 OG007 5 OG008 7 OG009 3 OG010 3 OG011 4 OG012 3 OG013 3 OG014 3 OG015 7 OG016 4 OG017 3 OG018 2 OG019 8 OG020 6 OG021 3 OG022 1 OG023 18
Title Denominators Categories Title Measurements OG000 6.900 ± 0.580 OG001 9.800 ± 0.490 OG002 23.400 ± 0.440 OG003 40.880 ± 0.270 OG004 29.190 ± 0.490 OG005 44.270 ± 0.640 OG006 120.260 ± 0.490 OG007 109.560 ± 0.490 OG008 116.630 ± 0.580 OG009 147.730 ± 0.410 OG010 159.020 ± 0.080 OG011 35.260 ± 0.560 OG012 48.930 ± 0.910 OG013 75.130 ± 0.110 OG014 114.890 ± 0.430 OG015 64.110 ± 0.460 OG016 78.700 ± 0.640 OG017 103.950 ± 0.470 OG018 95.370 ± 0.110 OG019 146.500 ± 0.580 OG020 146.010 ± 0.340 OG021 159.100 ± 0.650 OG022 190.000 ± NA Not evaluable OG023 98.210 ± 0.410
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
OG003 Phase 1 Cycle 2, Day 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
OG004 Phase 1 Cycle 1, Day 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
OG005 Phase 1 Cycle 2, Day 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
OG006 Phase 1 Cycle 1, Day 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
OG007 Phase 1 Cycle 2, Day 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
OG008 Phase 1 Cycle 1, Day 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
OG009 Phase 1 Cycle 2, Day 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
OG010 Phase 1 Cycle 1, Day 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
OG011 Phase 1 Cycle 1, Day 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
OG012 Phase 1 Cycle 2, Day 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
OG013 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
OG014 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
OG015 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
OG016 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
OG017 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
OG018 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
OG019 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
OG020 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
OG021 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
OG022 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
OG023 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.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 3 OG004 3 OG005 3 OG006 7 OG007 5 OG008 7 OG009 3 OG010 3 OG011 4 OG012 3 OG013 3 OG014 3 OG015 7 OG016 4 OG017 3 OG018 2 OG019 8 OG020 6 OG021 3 OG022 1 OG023 18
Title Denominators Categories Title Measurements OG000 2.0 (1.1 to 3.0) OG001 1.2 (1.0 to 2.0) OG002 1.1 (1.0 to 2.0) OG003 1.1 (1.0 to 2.0) OG004 3.0 (1.0 to 4.1) OG005 2.0 (1.1 to 4.0) OG006 1.1 (1.0 to 2.2) OG007 1.2 (1.0 to 2.2) OG008 1.0 (1.0 to 2.1) OG009 1.1 (1.0 to 2.1) OG010 2.0 (1.1 to 3.0) OG011 1.5 (1.0 to 2.2) OG012 1.0 (1.0 to 1.1) OG013 1.1 (0.8 to 2.0) OG014 1.1 (1.0 to 2.1) OG015 1.2 (0.6 to 2.2) OG016 1.1 (1.0 to 2.1) OG017 1.0 (1.0 to 2.0) OG018 2.0 (2.0 to 2.0) OG019 2.0 (0.5 to 3.0) OG020 2.0 (1.0 to 2.2) OG021 2.2 (2.1 to 3.1) OG022 1.0 (1.0 to 1.0) OG023 2.0 (0.6 to 3.0)
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
OG003 Phase 1 Cycle 2, Day 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
OG004 Phase 1 Cycle 1, Day 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
OG005 Phase 1 Cycle 2, Day 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
OG006 Phase 1 Cycle 1, Day 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
OG007 Phase 1 Cycle 2, Day 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
OG008 Phase 1 Cycle 1, Day 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
OG009 Phase 1 Cycle 2, Day 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
OG010 Phase 1 Cycle 1, Day 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
OG011 Phase 1 Cycle 1, Day 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
OG012 Phase 1 Cycle 2, Day 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
OG013 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
OG014 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
OG015 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
OG016 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
OG017 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
OG018 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
OG019 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
OG020 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
OG021 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
OG022 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
OG023 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.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 3 OG004 3 OG005 3 OG006 7 OG007 5 OG008 7 OG009 3 OG010 3 OG011 4 OG012 3 OG013 3 OG014 3 OG015 7 OG016 4 OG017 3 OG018 2 OG019 8 OG020 6 OG021 3 OG022 1 OG023 18
Title Denominators Categories Title Measurements OG000 34.040 ± 0.840 OG001 74.020 ± 0.830 OG002 180.060 ± 0.150 OG003 356.490 ± 0.160 OG004 258.460 ± 0.320 OG005 439.660 ± 0.620 OG006 823.980 ± 0.350 OG007 896.420 ± 0.540 OG008 1014.130 ± 0.650 OG009 1265.130 ± 0.410 OG010 1649.350 ± 0.250 OG011 230.800 ± 0.800 OG012 331.800 ± 1.760 OG013 692.230 ± 0.160 OG014 814.930 ± 0.460 OG015 344.540 ± 0.580 OG016 507.360 ± 0.740 OG017 575.060 ± 0.440 OG018 790.340 ± 0.110 OG019 1055.130 ± 0.250 OG020 1296.470 ± 0.370 OG021 1264.610 ± 0.320 OG022 1146.110 ± NA Not evaluable OG023 713.710 ± 0.480
Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily
OG003 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
OG004 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
OG005 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
OG006 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
OG007 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
OG008 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
OG009 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
OG010 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
OG011 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
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 7 OG004 7 OG005 3 OG006 4 OG007 3 OG008 7 OG009 3 OG010 8 OG011 3
Title Denominators Categories Complete response Title Measurements OG000 0 OG001 0 OG002 0 OG003 0 OG004 0 OG005 0 OG006 0 OG007 0 OG008 0 OG009 0 OG010 1 OG011 0
Partial response Stable disease Progressive disease Missing
OG003 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
OG004 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
OG005 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
OG006 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
OG007 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
OG008 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
OG009 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
OG010 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
OG011 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
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 7 OG004 7 OG005 3 OG006 4 OG007 3 OG008 7 OG009 3 OG010 8 OG011 3
Title Denominators Categories Title Measurements OG000 0 (0.0 to 70.8) OG001 0 (0.0 to 70.8) OG002 0 (0.0 to 70.8) OG003 0 (0.0 to 41.0) OG004 0 (0.0 to 41.0) OG005 0 (0.0 to 70.8) OG006 0 (0.0 to 60.2) OG007 0 (0.0 to 70.8) OG008 0 (0.0 to 41.0) OG009 33.3 (0.8 to 90.6) OG010 12.5 (0.3 to 52.7) OG011 0 (0.0 to 70.8)
OG000 18
OG001 13 Title Denominators Categories Title Measurements OG000 2.5 (1.4 to 7.5) OG001 3.5 (1.6 to NA) Value(s) could not be evaluable due insufficient number of participants with events
18
OG001 13 Title Denominators Categories Title Measurements OG000 31.3 (11.8 to 53.1) OG001 43.3 (16.3 to 67.9)
18
OG001 13 Title Denominators Categories Title Measurements OG000 42.9 (15.9 to 67.8) OG001 55.6 (20.4 to 80.5)
0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 1 events 1 affected 18 at risk 0 events
0 affected
7 at risk
EG004 1 events 1 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 1 events 1 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 1 events 1 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 1 events 1 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 1 events 1 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 1 events 1 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 1 events 1 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 1 events 1 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 1 events 1 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 2 events 2 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 1 events 1 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 1 events 1 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 1 events 1 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 2 events
2 affected
7 at risk
EG004 1 events 1 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 1 events
1 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 1 events 1 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 1 events
1 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 1 events 1 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 2 events 2 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 1 events 1 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 1 events 1 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 1 events 1 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 3 events 2 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 1 events 1 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 1 events 1 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 2 events 1 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 18 at risk 0 events
0 affected
7 at risk
EG004 0 events 0 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
EG012 2 events 1 affected 18 at risk 0 events
0 affected
7 at risk
EG004 1 events 1 affected 7 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 4 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 7 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 8 at risk
EG011 0 events 0 affected 3 at risk
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