Trial Outcomes & Findings for A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene (NCT NCT05469178)
NCT ID: NCT05469178
Last Updated: 2025-10-29
Results Overview
DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Cycle 1 (the first 21 days of treatment)
Results posted on
2025-10-29
Participant Flow
Study recruitment was undertaken across 7 planned countries: USA, France, Greece, Hungary, Italy, Poland \& Spain. Of these countries, 5 countries enrolled participants: USA (10 participants), France (5 participants), Greece (3 participants), Italy (2 participants) \& Spain (6 participants). The recruitment process began in March 2023 and concluded in February 2025. 65 participants were screened in order to successfully recruit 26 participants.
Participants were screened to the inclusion/exclusion criteria of the protocol. The following assessments were performed: Informed Consent, Demographics, Medical/Surgical History including NSCLC diagnosis and prior anticancer treatments, Pregnancy/FSH, ECOG performance score, Vital signs, Physical examination, Echocardiogram, Laboratory Safety Testing, ECG, Tumour imaging/sampling and biopsies \& blood sampling for genomic DNA/serum biomarkers.
Participant milestones
| Measure |
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)
Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
Phase 1b Cohort 1: Bemcentinib 75 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 75 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 100 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
Phase 1b Cohort 3: Bemcentinib 150 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 150 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
3
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
3
|
3
|
4
|
Reasons for withdrawal
| Measure |
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b)
Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
Phase 1b Cohort 1: Bemcentinib 75 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 75 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 100 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
Phase 1b Cohort 3: Bemcentinib 150 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 150 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin).
Bemcentinib: Bemcentinib capsules will be administered daily orally.
Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks.
Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days.
|
|---|---|---|---|---|
|
Overall Study
Death
|
6
|
1
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
10
|
2
|
2
|
1
|
Baseline Characteristics
A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene
Baseline characteristics by cohort
| Measure |
Phase 1b Cohort 1: Bemcentinib 75 mg
n=3 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
n=3 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 3: Bemcentinib 150 mg
n=4 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
n=16 Participants
Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Continuous
|
52.0 Years
STANDARD_DEVIATION 26.66 • n=5 Participants
|
71.0 Years
STANDARD_DEVIATION 3.46 • n=7 Participants
|
63.8 Years
STANDARD_DEVIATION 7.14 • n=5 Participants
|
61.2 Years
STANDARD_DEVIATION 11.67 • n=4 Participants
|
62.4 Years
STANDARD_DEVIATION 15.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Weight
|
75.30 Kilograms
n=5 Participants
|
82.00 Kilograms
n=7 Participants
|
71.30 Kilograms
n=5 Participants
|
70.50 Kilograms
n=4 Participants
|
73.75 Kilograms
n=21 Participants
|
|
Height
|
172.00 Centimetres
n=5 Participants
|
165.00 Centimetres
n=7 Participants
|
173.00 Centimetres
n=5 Participants
|
171.00 Centimetres
n=4 Participants
|
171.50 Centimetres
n=21 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (the first 21 days of treatment)Population: This analysis population included all 10 participants who were enrolled into Phase 1b of the study and completed at least one cycle of treatment for evaluation of DLT.
DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment.
Outcome measures
| Measure |
Phase 1b Cohort 1: Bemcentinib 75 mg
n=3 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
n=3 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 3: Bemcentinib 150 mg
n=4 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This analysis population included all 16 participants who were enrolled into Phase 2a of the study and completed sufficient cycles of treatment up to the 6-month timepoint.
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Outcome measures
| Measure |
Phase 1b Cohort 1: Bemcentinib 75 mg
n=16 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 3: Bemcentinib 150 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
|---|---|---|---|
|
Phase 2a: Objective Response Rate (ORR) at 6 Months
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This analysis population included all 16 participants who were enrolled into Phase 2a of the study and completed sufficient cycles of treatment up to the 12-month timepoint.
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Outcome measures
| Measure |
Phase 1b Cohort 1: Bemcentinib 75 mg
n=16 Participants
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 3: Bemcentinib 150 mg
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
|---|---|---|---|
|
Phase 2a: Objective Response Rate (ORR) at 12 Months
|
0 Participants
|
—
|
—
|
Adverse Events
Phase 1b Cohort 3: Bemcentinib 150 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
Serious events: 6 serious events
Other events: 15 other events
Deaths: 6 deaths
Phase 1b Cohort 1: Bemcentinib 75 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b Cohort 2: Bemcentinib 100 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1b Cohort 3: Bemcentinib 150 mg
n=4 participants at risk
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
n=16 participants at risk
Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 1: Bemcentinib 75 mg
n=3 participants at risk
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
n=3 participants at risk
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
|---|---|---|---|---|
|
Vascular disorders
Claudication in Peripheral Vascular Disease
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Embolic Stroke
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Chest Pain
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Platelets Count Decreased
|
25.0%
1/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Weight Loss
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Mucositis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Upper Digestive Bleeding
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Enterococcus Faecalis Infection
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Epigastralgia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Endocrine disorders
Secondary Adrenal Insufficiency
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
White Blood Cells Decrease
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Cardiac disorders
Atrial Fibrillation With RVR
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Bowel Perforation
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Vascular disorders
Thrombolic Event - Right Ventricle
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
Other adverse events
| Measure |
Phase 1b Cohort 3: Bemcentinib 150 mg
n=4 participants at risk
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b)
n=16 participants at risk
Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 1: Bemcentinib 75 mg
n=3 participants at risk
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
Phase 1b Cohort 2: Bemcentinib 100 mg
n=3 participants at risk
Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only.
|
|---|---|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
75.0%
3/4 • Number of events 6 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
25.0%
4/16 • Number of events 6 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
31.2%
5/16 • Number of events 9 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
50.0%
2/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on Exertion
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Erythematous Lesions of the Anterior Face, Torso and Dorsal Root and Legs, Pruritic
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
25.0%
4/16 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Inappetence
|
50.0%
2/4 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
25.0%
4/16 • Number of events 8 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Large Pleural Effusion
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 12 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
100.0%
3/3 • Number of events 6 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 6 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
18.8%
3/16 • Number of events 5 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Acid Reflux
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Vascular disorders
Claudication in Peripheral Vascular Disease
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
25.0%
4/16 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Hand Itching
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Head Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Short of Breath
|
50.0%
2/4 • Number of events 5 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Swollen Legs
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
37.5%
6/16 • Number of events 10 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Embolic Stroke
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Feeling Frail
|
50.0%
2/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
25.0%
4/16 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Generalised Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Worsening Hyperlipidemia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Reproductive system and breast disorders
Worsening of Prostatic Hyperplasia with Urinary Frequency
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Bronchial Infection
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Renal and urinary disorders
Chronic Renal Failure
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
COVID-19 Infection
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Lower Limb Edema
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain in Arms and Thighs
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Chest Pain
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Pyelonephritis E.coli Urinary Tract Infection
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Serious Otitis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Immune system disorders
Unknown Allergic Reaction
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 5 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
31.2%
5/16 • Number of events 6 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Creatinine Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
18.8%
3/16 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Average QTCF Greater than 450ms
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Conjunctivitis Immunomediated
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Erythema Face and Chest
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Folliculitis
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Lipase Increased
|
25.0%
1/4 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Melanoderma
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Mucositis Oral
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrheic Keratosis
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Trunk Rash
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Eye disorders
Watery Eyes
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Deterioration of General Condition
|
50.0%
2/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Platelets Count Decreased
|
25.0%
1/4 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
18.8%
3/16 • Number of events 6 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Weight Loss
|
50.0%
2/4 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Bulbar Gastric Ulcer
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Eosinophil Count Increased
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Increased Alkaline Phosphatase
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
31.2%
5/16 • Number of events 5 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Increased Basophils
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Increased Lactate Dehydrogenase
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Increased Neutrophils
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Monocytosis
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Non-Pruritic Maculopapular Skin Lesions of the Extremities
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Platelet Count Increased
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Psychiatric disorders
Anxiety Worsening
|
25.0%
1/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Electrocardiogram QT Corrected Interval Prolonged
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 5 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Neutrophil Count Decreased
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/16 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
White Blood Cells Decreased
|
25.0%
1/4 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
18.8%
3/16 • Number of events 4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Amylase Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Eye disorders
Dry Eye
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Upper and Lower Respiratory Tract Infection
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Body Rash
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Edema in Left Lower Extremity
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Femoral Oncologic Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Oral Pain due to Mucositis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Feet and Hand Edema
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Gamma Glutamyltransferase Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Influenza A Virus Infection
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Skin Foot Lesion
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Upper Digestive Bleeding
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Bilateral and Dorsal Chest Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Mucosity (Site Unknown)
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Skin Rash on the Chest
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Infections and infestations
Entercoccus Faecalis Infection
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Epigastralgia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Endocrine disorders
Secondary Adrenal Insufficiency
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Lymphocytes Count Decreased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Injury, poisoning and procedural complications
Malleolus Fracture
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Endocrine disorders
Thyroid Nodule
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Nervous system disorders
Cranial Theca Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Left Shoulder Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Right Arm Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
18.8%
3/16 • Number of events 3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Rash (Lateral Thigh)
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Edema
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Cardiac disorders
Atrial Fibrillation with RVR
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
Grade 3 Lymphocyte Count Decreased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxic Respiratory Failure
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Gastrointestinal disorders
Bowel Perforation
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Skin and subcutaneous tissue disorders
Impaired Skin Integrity around Nail Bed
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
|
Vascular disorders
Thrombolic Event - Right Ventricle
|
0.00%
0/4 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
0.00%
0/3 • Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure agreement outlines that PIs are not to disclose study results without prior discussion with the study Sponsor
- Publication restrictions are in place
Restriction type: OTHER