Trial Outcomes & Findings for NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours (NCT NCT05714553)
NCT ID: NCT05714553
Last Updated: 2026-07-23
Results Overview
The outcome measure presented is the number of DLTs per module
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2
Results posted on
2026-07-23
Participant Flow
A total of 26 patients were screened and 19 patients were enrolled across 3 sites in the UK between March 2023 and May 2025.
This study was a modular Phase Ib/II study, with each module consisting of a Phase Ib dose-validation phase and a potential Phase II dose-expansion phase. However, the Phase II dose-expansion phase was not initiated in either module. All participants reported in the Participant Flow were enrolled in the Phase Ib part. Arms/groups were combined within each module because no participants were assigned to or treated in any Phase II expansion arm.
Participant milestones
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
4
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
|---|---|---|
|
Overall Study
Progressive disease
|
9
|
3
|
|
Overall Study
Not treated
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours
Baseline characteristics by cohort
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
n=15 Participants
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
n=4 Participants
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 Years
n=9 Participants
|
67.5 Years
n=27 Participants
|
69.0 Years
n=267 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Primary tumor location
Cutaneous melanoma
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Primary tumor location
Bladder (urothelial)
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Primary tumor location
Oropharyngeal
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Primary tumor location
NSCLC
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Primary tumor location
Pleural mesothelioma
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Primary tumor location
Anal
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Primary tumor location
Sinonasal
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Primary tumor location
Pancreatic
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Primary tumor location
Rectal
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Tumor stage
Stage I
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Tumor stage
Stage III
|
7 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Tumor stage
Stage IV
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Tumor stage
Unknown
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Tumor stage
Stage II
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
ECOG performance status
0
|
5 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
ECOG performance status
1
|
10 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2Population: The safety population was used and consisted of all patients who received at least one dose of study treatment (n=13 in Module 1 and n=4 in Module 2).
The outcome measure presented is the number of DLTs per module
Outcome measures
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
n=13 Participants
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
n=4 Participants
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
|---|---|---|
|
Number of Participants With DLTs in Each Module
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed from baseline to 30 days after last dose of study drug, up to 20 monthsPopulation: The evaluable for response population was used and included all patients with measurable disease at baseline who had undergone at least two cycles of treatment, received at least 75% of planned treatment over the two cycles, and undergone a post-treatment objective disease assessment.
Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and by immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
n=9 Participants
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
n=3 Participants
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
|---|---|---|
|
Number of Patients Achieving a Reduction in Tumour Volume (Objective Response Rate; ORR)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed from baseline to 30 days after the last dose of study drug, up to 20 monthsDisease control rate, defined as the number of patients achieving a response (CR or PR) or stable disease (SD) as their best overall response. Disease control was measured by MRI scan and assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease
Outcome measures
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
n=9 Participants
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
n=3 Participants
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
|---|---|---|
|
Number of Patients Achieving a Reduction or Stabilisation in Tumor Volume (Disease Control Rate; DCR)
|
6 Participants
|
2 Participants
|
Adverse Events
Module 1 (NUC-3373 + LV + Pembrolizumab)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 10 deaths
Module 2 (NUC-3373 + LV + Docetaxel)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
n=13 participants at risk
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
n=4 participants at risk
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Kidney infection
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 3 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
Other adverse events
| Measure |
Module 1 (NUC-3373 + LV + Pembrolizumab)
n=13 participants at risk
This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
Module 2 (NUC-3373 + LV + Docetaxel)
n=4 participants at risk
This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
69.2%
9/13 • Number of events 20 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
53.8%
7/13 • Number of events 16 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 8 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
69.2%
9/13 • Number of events 14 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 7 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
46.2%
6/13 • Number of events 9 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 3 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • Number of events 5 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Angular cheilitis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Colitis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
4/13 • Number of events 9 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
38.5%
5/13 • Number of events 6 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
1/13 • Number of events 4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Neutrophil count increased
|
7.7%
1/13 • Number of events 4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
White blood cell count increased
|
7.7%
1/13 • Number of events 4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Lipase increased
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Platelet count increased
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.8%
4/13 • Number of events 14 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
7.7%
1/13 • Number of events 3 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 3 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
38.5%
5/13 • Number of events 20 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
53.8%
7/13 • Number of events 13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 6 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Pneumonia
|
23.1%
3/13 • Number of events 6 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Conjuctivitis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Gingivitis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Oral candidiasis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Rhinitis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.8%
4/13 • Number of events 5 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
General disorders
Fatigue
|
46.2%
6/13 • Number of events 6 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 5 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
General disorders
Chest discomfort
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
General disorders
Influenza-like illness
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 3 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13 • Number of events 4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Contusion
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Nervous system disorders
Dysguesia
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Nervous system disorders
Hypoasthesia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Nervous system disorders
Paraesthesia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Renal and urinary disorders
Hematuria
|
15.4%
2/13 • Number of events 5 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Vascular disorders
Hot flush
|
7.7%
1/13 • Number of events 3 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Vascular disorders
Flushing
|
15.4%
2/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Vascular disorders
Embolism venous
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
50.0%
2/4 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Cardiac disorders
Atrial flutter
|
7.7%
1/13 • Number of events 2 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Cardiac disorders
Bradycardia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Cardiac disorders
Extrasystoles
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Vascular disorders
Sinus tachycardia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
3/13 • Number of events 4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Eye disorders
Dry eye
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Eye disorders
Vitreous floaters
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor ulceration
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Reproductive system and breast disorders
Perineal ulceration
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Reproductive system and breast disorders
Prostatic hemorrhage
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/13 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
25.0%
1/4 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
|
Ear and labyrinth disorders
Deafness transitory
|
7.7%
1/13 • Number of events 1 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
0.00%
0/4 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
|
Additional Information
Medical and Scientific Affairs Department
NuCana plc
Phone: +44 131 357 1111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place