Trial Outcomes & Findings for A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer (NCT NCT05678257)
NCT ID: NCT05678257
Last Updated: 2025-09-12
Results Overview
PFS assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, defined as the time from randomisation to the first observation of objective tumour progression or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Assessed from baseline to 30 days after last dose of study drug, up to 16 months
Results posted on
2025-09-12
Participant Flow
A total of 180 patients were randomized between April 2023 and August 2024
Participant milestones
| Measure |
NUFIRI-bev Q1W
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
65
|
58
|
|
Overall Study
COMPLETED
|
35
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
22
|
31
|
26
|
Reasons for withdrawal
| Measure |
NUFIRI-bev Q1W
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
|
Overall Study
Progressive disease
|
11
|
18
|
7
|
|
Overall Study
No longer clinically benefitting
|
2
|
1
|
0
|
|
Overall Study
Sponsor decision
|
5
|
9
|
8
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Patient non-compliance
|
0
|
0
|
3
|
Baseline Characteristics
A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer
Baseline characteristics by cohort
| Measure |
NUFIRI-bev Q1W
n=57 Participants
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
n=65 Participants
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
n=58 Participants
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 Years
n=93 Participants
|
64.0 Years
n=4 Participants
|
65.0 Years
n=27 Participants
|
64.0 Years
n=483 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
72 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
108 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
128 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
ECOG performance status
0
|
31 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
105 Participants
n=483 Participants
|
|
ECOG performance status
1
|
25 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
71 Participants
n=483 Participants
|
|
ECOG performance status
Not reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage I (A-C)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage II (A-C)
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage IIIA
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage IIIB
|
4 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage IIIC
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage IV
|
30 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
82 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage IVA
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage IVB
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Stage IVC
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Stage at initial diagnosis
Not reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Primary tumor location
Colon - right side
|
15 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
56 Participants
n=483 Participants
|
|
Primary tumor location
Colon - left side
|
20 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Primary tumor location
Colon - unknown
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Primary tumor location
Rectum
|
16 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Liver metastases
Yes
|
46 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
126 Participants
n=483 Participants
|
|
Liver metastases
No
|
11 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
54 Participants
n=483 Participants
|
|
Number of metastatic sites
1
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Number of metastatic sites
2
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Number of metastatic sites
3
|
19 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
|
Number of metastatic sites
4 or more
|
28 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
92 Participants
n=483 Participants
|
|
Number of metastatic sites
Not reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Assessed from baseline to 30 days after last dose of study drug, up to 16 monthsPFS assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, defined as the time from randomisation to the first observation of objective tumour progression or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.
Outcome measures
| Measure |
NUFIRI-bev Q1W
n=57 Participants
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
n=65 Participants
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
n=58 Participants
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
|---|---|---|---|
|
Median Progress-free Survival (PFS)
|
5.68 Months
Interval 0.03 to 11.17
|
5.52 Months
Interval 0.03 to 10.84
|
9.03 Months
Interval 0.03 to 15.01
|
SECONDARY outcome
Timeframe: Assessed from baseline to 30 days after last dose of study drug, up to 16 monthsObjective 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: 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 |
NUFIRI-bev Q1W
n=57 Participants
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
n=65 Participants
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
n=58 Participants
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
|---|---|---|---|
|
Number of Patients Achieving a Reduction in Tumour Volume
|
4 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Assessed from baseline to 30 days after last dose of study drug, up to 16 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: 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 |
NUFIRI-bev Q1W
n=57 Participants
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
n=65 Participants
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
n=58 Participants
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
|---|---|---|---|
|
Number of Patients Achieving Disease Control
|
35 Participants
|
42 Participants
|
46 Participants
|
Adverse Events
NUFIRI-bev Q1W
Serious events: 11 serious events
Other events: 55 other events
Deaths: 18 deaths
NUFIRI-bev Q2W
Serious events: 13 serious events
Other events: 62 other events
Deaths: 14 deaths
FOLFIRI-bev Q2W
Serious events: 17 serious events
Other events: 57 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NUFIRI-bev Q1W
n=56 participants at risk
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
n=64 participants at risk
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
n=57 participants at risk
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatobiliary cancer
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Pyrexia
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Catheter site extravasation
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Complication associated with device
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Inadequate analgesia
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Cardiac disorders
Stress cardiomyopathy
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
2/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.6%
2/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.5%
2/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
3.6%
2/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Hepatobiliary disorders
Intrahepatic portal hepatic venous fistula
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Biliary tract infection
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Rectal abscess
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
Other adverse events
| Measure |
NUFIRI-bev Q1W
n=56 participants at risk
Arm A: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
|
NUFIRI-bev Q2W
n=64 participants at risk
Arm B: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15
|
FOLFIRI-bev Q2W
n=57 participants at risk
Arm C: Study treatment will be administered in 28-day cycles as follows:
1. Bevacizumab 5 mg/kg on Days 1 and 15:
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
8.9%
5/56 • Number of events 12 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
17.2%
11/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
14.0%
8/57 • Number of events 12 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Asthenia
|
44.6%
25/56 • Number of events 45 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
35.9%
23/64 • Number of events 56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
45.6%
26/57 • Number of events 60 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Fatigue
|
17.9%
10/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
21.9%
14/64 • Number of events 23 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
19.3%
11/57 • Number of events 18 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Pyrexia
|
16.1%
9/56 • Number of events 12 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
14.1%
9/64 • Number of events 10 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
8.8%
5/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Mucosal inflammation
|
8.9%
5/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
4.7%
3/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
15.8%
9/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Influenza-like illness
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
8.8%
5/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
10.9%
7/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
12.3%
7/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
General disorders
Cough
|
12.5%
7/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
9.4%
6/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
2/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
9.4%
6/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
10.5%
6/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.7%
6/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
4.7%
3/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.0%
4/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
4.7%
3/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.8%
5/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
12.3%
7/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
14/56 • Number of events 46 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.0%
4/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
17.9%
10/56 • Number of events 32 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
8.8%
5/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
10.9%
7/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
8.8%
5/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Neutrophil count decreased
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
19.3%
11/57 • Number of events 18 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Weight decreased
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
8.8%
5/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Blood bilirubin increased
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Platelet count decreased
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
4.7%
3/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Nervous system disorders
Headache
|
23.2%
13/56 • Number of events 25 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
9.4%
6/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.5%
2/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Nervous system disorders
Dysgeusia
|
3.6%
2/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
10.5%
6/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.5%
2/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Nervous system disorders
Dizziness
|
3.6%
2/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.5%
2/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/56 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
28.1%
16/57 • Number of events 28 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
7/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
14.1%
9/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
8.8%
5/57 • Number of events 10 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.9%
5/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
4.7%
3/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
4.7%
3/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
62.5%
35/56 • Number of events 113 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
51.6%
33/64 • Number of events 79 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
49.1%
28/57 • Number of events 76 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
51.8%
29/56 • Number of events 81 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
57.8%
37/64 • Number of events 80 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
38.6%
22/57 • Number of events 51 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
39.3%
22/56 • Number of events 40 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
28.1%
18/64 • Number of events 41 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
15.8%
9/57 • Number of events 30 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
32.1%
18/56 • Number of events 30 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
20.3%
13/64 • Number of events 22 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
14.0%
8/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
23.2%
13/56 • Number of events 21 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
10.9%
7/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
22.8%
13/57 • Number of events 19 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
7/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
9.4%
6/64 • Number of events 10 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
21.1%
12/57 • Number of events 23 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.9%
5/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.8%
5/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.0%
4/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
4/56 • Number of events 11 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.8%
5/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.0%
4/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
4.7%
3/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasemia
|
7.1%
4/56 • Number of events 11 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
24.6%
14/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.5%
2/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.6%
11/56 • Number of events 12 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.0%
4/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
3.1%
2/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/64 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
7.0%
4/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
COVID-19
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Influenza
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
0.00%
0/57 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.2%
13/56 • Number of events 18 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
17.2%
11/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
28.1%
16/57 • Number of events 22 • Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
3/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
6.2%
4/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
5.3%
3/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
4/56 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.6%
1/64 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm did not receive any study treatment.
|
1.8%
1/57 • 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 treatment, up to 16 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 is one less patient per arm in the safety population as one patient per arm 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