Trial Outcomes & Findings for A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment (NCT NCT03428958)
NCT ID: NCT03428958
Last Updated: 2025-04-23
Results Overview
Efficacy (per RECIST v 1.1): defined as the best percentage change from baseline in tumour size (mm)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)
Results posted on
2025-04-23
Participant Flow
A total of 111 patients were recruited between July 2018 and June 2023.
No participants were recruited in Arms 1d, 2c, 2d, 3b, 3d, 3e, 3f, and 3g
Participant milestones
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 1500 mg/m2 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 2500 mg/m2 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Leucovorin (LV); Combination Chemotherapy Ineligible
Arm 1d: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Oxaliplatin (NUFOX) Expansion
Arm 2c: At the completion of Arm 2a, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan (NUFIRI) Expansion
Arm 2d: At the completion of Arm 2b, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFOX + Bevacizumab Every Other Week
Arm 3b: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV+oxaliplatin+bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
NUFIRI + Bevacizumab Every Other Week
Arm 3d: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV+irinotecan+bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
NUC-3373 + LV + Bevacizumab; Maintenance Patients
Arm 3e: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with bevacizumab (administered every other week).
NUC-3373 + bevacizumab: NUC-3373 + bevacizumab
|
NUFOX + Cetuximab
Arm 3f: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, oxaliplatin will be administered every other week and cetuximab will be administered weekly.
NUFOX + EGFR inhibitor: NUC-3373 + oxaliplatin + cetuximab/panitumumab
|
NUFIRI + Cetuximab
Arm 3g: NUC-3373, LV and irinotecan at dose levels used in Arm 2b may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, irinotecan will be administered every other week and cetuximab will be administered weekly.
NUFIRI + EGFR inhibitor: NUC-3373 + irinotecan + cetuximab/panitumumab
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
12
|
6
|
0
|
23
|
25
|
9
|
0
|
0
|
5
|
0
|
9
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
12
|
6
|
0
|
23
|
25
|
9
|
0
|
0
|
5
|
0
|
9
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 1500 mg/m2 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 2500 mg/m2 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Leucovorin (LV); Combination Chemotherapy Ineligible
Arm 1d: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Oxaliplatin (NUFOX) Expansion
Arm 2c: At the completion of Arm 2a, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan (NUFIRI) Expansion
Arm 2d: At the completion of Arm 2b, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFOX + Bevacizumab Every Other Week
Arm 3b: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV+oxaliplatin+bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
NUFIRI + Bevacizumab Every Other Week
Arm 3d: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV+irinotecan+bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
NUC-3373 + LV + Bevacizumab; Maintenance Patients
Arm 3e: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with bevacizumab (administered every other week).
NUC-3373 + bevacizumab: NUC-3373 + bevacizumab
|
NUFOX + Cetuximab
Arm 3f: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, oxaliplatin will be administered every other week and cetuximab will be administered weekly.
NUFOX + EGFR inhibitor: NUC-3373 + oxaliplatin + cetuximab/panitumumab
|
NUFIRI + Cetuximab
Arm 3g: NUC-3373, LV and irinotecan at dose levels used in Arm 2b may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, irinotecan will be administered every other week and cetuximab will be administered weekly.
NUFIRI + EGFR inhibitor: NUC-3373 + irinotecan + cetuximab/panitumumab
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Clinical Progression
|
2
|
3
|
2
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progression per RECIST
|
6
|
6
|
7
|
4
|
0
|
7
|
8
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
2
|
2
|
0
|
0
|
0
|
7
|
9
|
6
|
0
|
0
|
3
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician/Sponsor Decision
|
1
|
0
|
1
|
0
|
0
|
2
|
2
|
2
|
0
|
0
|
2
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
2
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment
Baseline characteristics by cohort
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
n=11 Participants
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=11 Participants
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=12 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 1500 mg/m2 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=6 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 2500 mg/m2 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Leucovorin (LV); Combination Chemotherapy Ineligible
Arm 1d: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=23 Participants
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=25 Participants
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=9 Participants
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Oxaliplatin (NUFOX) Expansion
Arm 2c: At the completion of Arm 2a, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan (NUFIRI) Expansion
Arm 2d: At the completion of Arm 2b, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=5 Participants
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFOX + Bevacizumab Every Other Week
Arm 3b: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV+oxaliplatin+bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=9 Participants
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
NUFIRI + Bevacizumab Every Other Week
Arm 3d: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV+irinotecan+bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
NUC-3373 + LV + Bevacizumab; Maintenance Patients
Arm 3e: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with bevacizumab (administered every other week).
NUC-3373 + bevacizumab: NUC-3373 + bevacizumab
|
NUFOX + Cetuximab
Arm 3f: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, oxaliplatin will be administered every other week and cetuximab will be administered weekly.
NUFOX + EGFR inhibitor: NUC-3373 + oxaliplatin + cetuximab/panitumumab
|
NUFIRI + Cetuximab
Arm 3g: NUC-3373, LV and irinotecan at dose levels used in Arm 2b may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, irinotecan will be administered every other week and cetuximab will be administered weekly.
NUFIRI + EGFR inhibitor: NUC-3373 + irinotecan + cetuximab/panitumumab
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.1 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
55.4 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
—
|
58.3 Years
STANDARD_DEVIATION 10.0 • n=10 Participants
|
56.7 Years
STANDARD_DEVIATION 10.1 • n=115 Participants
|
55.3 Years
STANDARD_DEVIATION 10 • n=24 Participants
|
—
|
—
|
65 Years
STANDARD_DEVIATION 5.9 • n=42 Participants
|
—
|
54.3 Years
STANDARD_DEVIATION 14.2 • n=36 Participants
|
—
|
—
|
—
|
—
|
57 Years
STANDARD_DEVIATION 10.5 • n=44 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
—
|
12 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
—
|
—
|
2 Participants
n=42 Participants
|
—
|
3 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
51 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
—
|
11 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
—
|
—
|
3 Participants
n=42 Participants
|
—
|
6 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
60 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
—
|
—
|
0 Participants
n=42 Participants
|
—
|
0 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
4 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
—
|
21 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
—
|
—
|
4 Participants
n=42 Participants
|
—
|
7 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
99 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
—
|
—
|
1 Participants
n=42 Participants
|
—
|
2 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
8 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
—
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
—
|
—
|
0 Participants
n=42 Participants
|
—
|
0 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
—
|
—
|
1 Participants
n=42 Participants
|
—
|
1 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
7 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
—
|
—
|
0 Participants
n=42 Participants
|
—
|
0 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
—
|
—
|
0 Participants
n=42 Participants
|
—
|
1 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
5 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
—
|
20 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
—
|
—
|
4 Participants
n=42 Participants
|
—
|
7 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
93 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
—
|
—
|
0 Participants
n=42 Participants
|
—
|
0 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
—
|
—
|
0 Participants
n=42 Participants
|
—
|
0 Participants
n=36 Participants
|
—
|
—
|
—
|
—
|
4 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)Population: Evaluable for Response (EFR): Patients with measurable disease at baseline who received at least two cycles of study treatment (receiving at least 75% of the planned doses over the two cycles) and had a post-treatment objective disease assessment. Data are only available for patients in the EFR set who did not have a best response of progressive disease and who had evaluable post-dose target lesion data. All patients in Arm 1a had a best response of either progressive disease or non-evaluable.
Efficacy (per RECIST v 1.1): defined as the best percentage change from baseline in tumour size (mm)
Outcome measures
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=4 Participants
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=5 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=2 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=8 Participants
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=9 Participants
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=2 Participants
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=4 Participants
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=8 Participants
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Tumour Size
|
—
|
8.3 Percent change
Interval -15.0 to 20.0
|
2.9 Percent change
Interval -28.0 to 15.0
|
3.2 Percent change
Interval -3.0 to 9.0
|
2.3 Percent change
Interval -19.0 to 10.0
|
7.9 Percent change
Interval -12.0 to 21.0
|
2.8 Percent change
Interval -2.0 to 8.0
|
-13.9 Percent change
Interval -18.0 to -12.0
|
-11.1 Percent change
Interval -26.0 to 5.0
|
PRIMARY outcome
Timeframe: Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)Population: Evaluable for Response (EFR): Patients with measurable disease at baseline who received at least two cycles of study treatment (receiving at least 75% of the planned doses over the two cycles) and had a post-treatment objective disease assessment. Data are only available for patients in the EFR set achieving confirmed response (CR and PR) or stable disease (SD) as the best overall response.
Efficacy (per RECIST v 1.1): defined as the proportion of patients achieving confirmed response (CR and PR) or stable disease (SD) as the best overall response
Outcome measures
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
n=3 Participants
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=7 Participants
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=8 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=4 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=15 Participants
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=14 Participants
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=6 Participants
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=5 Participants
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=9 Participants
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
0 percentage of patients
|
42.9 percentage of patients
|
62.5 percentage of patients
|
50 percentage of patients
|
46.7 percentage of patients
|
42.9 percentage of patients
|
33.3 percentage of patients
|
80.0 percentage of patients
|
88.9 percentage of patients
|
PRIMARY outcome
Timeframe: Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)Population: Evaluable for Response (EFR): Patients with measurable disease at baseline who received at least two cycles of study treatment (receiving at least 75% of the planned doses over the two cycles) and had a post-treatment objective disease assessment. Data are only available for patients in the EFR set who did not have a best response of progressive disease and who had evaluable post-dose target lesion data and had Stable Disease.
Efficacy (per RECIST v 1.1): defined as the time from the time measurement criteria are first met for SD until the first date that recurrence or progressive disease (PD) is objectively documented
Outcome measures
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=3 Participants
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=5 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=2 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=7 Participants
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=6 Participants
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=2 Participants
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=4 Participants
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=8 Participants
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Stable Disease (DoSD)
|
—
|
1.9 months
Interval 1.9 to 4.8
|
2.6 months
Interval 0.03 to 3.3
|
1.9 months
Interval 1.9 to 1.9
|
3.7 months
Interval 0.03 to 4.4
|
3.2 months
Interval 2.0 to 8.6
|
2.3 months
Interval 2.0 to 2.5
|
6.5 months
Interval 5.3 to 7.9
|
4.6 months
Interval 0.2 to 13.2
|
PRIMARY outcome
Timeframe: Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)Population: Patients who received at least one dose of NUC-3373
Efficacy (per RECIST v 1.1): defined as the time from first dose of study treatment until the date of objective disease progression or death
Outcome measures
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
n=10 Participants
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=11 Participants
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=11 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=6 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=23 Participants
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=23 Participants
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=8 Participants
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=5 Participants
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=9 Participants
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
1.7 months
Interval 0.03 to 2.1
|
2.3 months
Interval 0.03 to 4.2
|
2.9 months
Interval 0.03 to 5.0
|
1.8 months
Interval 0.03 to 3.6
|
2.5 months
Interval 0.03 to 6.1
|
3.6 months
Interval 0.03 to 6.5
|
2.0 months
Interval 0.03 to 4.1
|
7.7 months
Interval 2.3 to 9.8
|
5.5 months
Interval 1.9 to 15.0
|
PRIMARY outcome
Timeframe: From the date of randomization until the date of death from any cause, until the end of study (up to 25 months)]Population: Full Analysis Set: All randomised patients
Efficacy: defined as the time from randomization until the date of death from any cause
Outcome measures
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
n=11 Participants
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=11 Participants
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=12 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=6 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=23 Participants
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=25 Participants
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=9 Participants
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=5 Participants
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=9 Participants
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
1.9 months
Interval 0.9 to 3.3
|
3.0 months
Interval 1.5 to 7.7
|
3.6 months
Interval 0.8 to 8.0
|
3.6 months
Interval 1.3 to 5.5
|
3.4 months
Interval 0.4 to 24.5
|
3.2 months
Interval 0.5 to 19.1
|
7.3 months
Interval 1.4 to 13.6
|
14.2 months
Interval 9.4 to 16.9
|
12.8 months
Interval 3.2 to 18.2
|
PRIMARY outcome
Timeframe: Assessed every 8 weeks from Day 1 until the end of study (up to 25 months)Population: Evaluable for Response (EFR): Patients with measurable disease at baseline who received at least two cycles of study treatment (receiving at least 75% of the planned doses over the two cycles) and had a post-treatment objective disease assessment.
Best overall response to study treatment according to RECIST v1.1
Outcome measures
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
n=3 Participants
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=7 Participants
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=8 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=4 Participants
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=15 Participants
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=14 Participants
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=6 Participants
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=5 Participants
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=9 Participants
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response
Complete Response
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response
Partial Response
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response
Stable Disease
|
0 percentage of participants
|
42.9 percentage of participants
|
62.5 percentage of participants
|
50 percentage of participants
|
46.7 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
80.0 percentage of participants
|
88.9 percentage of participants
|
|
Best Overall Response
Progressive Disease
|
100.0 percentage of participants
|
42.9 percentage of participants
|
37.5 percentage of participants
|
50.0 percentage of participants
|
46.7 percentage of participants
|
42.9 percentage of participants
|
66.7 percentage of participants
|
20.0 percentage of participants
|
11.1 percentage of participants
|
|
Best Overall Response
Not Evaluable
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
NUC-3373 + Leucovorin (LV) Every Other Week
Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths
NUC-3373 Every Other Week
Serious events: 2 serious events
Other events: 11 other events
Deaths: 4 deaths
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
NUC-3373 + Oxaliplatin Weekly
Serious events: 11 serious events
Other events: 23 other events
Deaths: 11 deaths
NUC-3373 + Irinotecan Weekly
Serious events: 8 serious events
Other events: 23 other events
Deaths: 11 deaths
NUC-3373 + Irinotecan Weekly (PK Sub-study)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 6 deaths
NUFOX + Bevacizumab Weekly
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
NUFIRI + Bevacizumab Weekly
Serious events: 4 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
n=10 participants at risk
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=11 participants at risk
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=11 participants at risk
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=6 participants at risk
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=23 participants at risk
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=23 participants at risk
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=8 participants at risk
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=5 participants at risk
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=9 participants at risk
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Fatigue
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Secretion discharge
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Lower respiratory tract infection
|
30.0%
3/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Injury, poisoning and procedural complications
Drain site complication
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Spinal cord compression
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
Other adverse events
| Measure |
NUC-3373 + Leucovorin (LV) Every Other Week
n=10 participants at risk
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 Every Other Week
n=11 participants at risk
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373: NUC-3373
|
NUC-3373 (1500 mg/m2) + Leucovorin (LV) Weekly
n=11 participants at risk
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 (2500 mg/m2) + Leucovorin (LV) Weekly
n=6 participants at risk
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin: NUC-3373 + leucovorin
|
NUC-3373 + Oxaliplatin Weekly
n=23 participants at risk
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUFOX: NUC-3373 + oxaliplatin
|
NUC-3373 + Irinotecan Weekly
n=23 participants at risk
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUC-3373 + Irinotecan Weekly (PK Sub-study)
n=8 participants at risk
Arm 2b (PK sub-study): NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFIRI: NUC-3373 + irinotecan
|
NUFOX + Bevacizumab Weekly
n=5 participants at risk
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + VEGF pathway inhibitor: NUC-3373 + oxaliplatin + bevacizumab
|
NUFIRI + Bevacizumab Weekly
n=9 participants at risk
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + VEGF pathway inhibitor: NUC-3373 + irinotecan + bevacizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
36.4%
4/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
43.5%
10/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
43.5%
10/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
37.5%
3/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
60.0%
3/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
3/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Eye disorders
Hypoaesthesia eye
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal hernia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
45.5%
5/11 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
3/6 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
21.7%
5/23 • Number of events 7 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
30.4%
7/23 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
4/8 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
44.4%
4/9 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
3/6 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
36.4%
4/11 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
34.8%
8/23 • Number of events 13 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 7 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
4/8 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
60.0%
3/5 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
36.4%
4/11 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
27.3%
3/11 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
43.5%
10/23 • Number of events 27 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
65.2%
15/23 • Number of events 21 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
4/8 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
80.0%
4/5 • Number of events 11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
88.9%
8/9 • Number of events 16 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
27.3%
3/11 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
63.6%
7/11 • Number of events 9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
66.7%
4/6 • Number of events 18 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
56.5%
13/23 • Number of events 24 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
56.5%
13/23 • Number of events 20 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
4/8 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
100.0%
5/5 • Number of events 12 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
55.6%
5/9 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Rectal discharge
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
2/10 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
72.7%
8/11 • Number of events 11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
66.7%
4/6 • Number of events 10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
56.5%
13/23 • Number of events 26 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
34.8%
8/23 • Number of events 9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
25.0%
2/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
80.0%
4/5 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
55.6%
5/9 • Number of events 7 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Asthenia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
26.1%
6/23 • Number of events 9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Chills
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Device related thrombosis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
83.3%
5/6 • Number of events 13 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
65.2%
15/23 • Number of events 24 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
34.8%
8/23 • Number of events 15 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
100.0%
8/8 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
80.0%
4/5 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
66.7%
6/9 • Number of events 9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Feeling hot
|
20.0%
2/10 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Localised oedema
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Malaise
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Mucosal inflammation
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
25.0%
2/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Body tinea
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Lower respiratory tract infection
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Sweating fever
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
3/9 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Injury, poisoning and procedural complications
Stoma site pruritus
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
26.1%
6/23 • Number of events 9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
55.6%
5/9 • Number of events 12 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
21.7%
5/23 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
55.6%
5/9 • Number of events 15 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Blood iron decreased
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Lipase increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Vitamin B12 decreased
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
Weight decreased
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
39.1%
9/23 • Number of events 9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
26.1%
6/23 • Number of events 7 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
25.0%
2/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
25.0%
2/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
37.5%
3/8 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
21.7%
5/23 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
25.0%
2/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Cold dysaesthesia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
21.7%
5/23 • Number of events 8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Lethargy
|
20.0%
2/10 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
100.0%
5/5 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
30.4%
7/23 • Number of events 7 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
27.3%
3/11 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
27.3%
3/11 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
18.2%
2/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
2/6 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
25.0%
2/8 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
22.2%
2/9 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
20.0%
1/5 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
16.7%
1/6 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Vascular disorders
Flushing
|
40.0%
4/10 • Number of events 7 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
3/6 • Number of events 5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
17.4%
4/23 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
8.7%
2/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
40.0%
2/5 • Number of events 2 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
11.1%
1/9 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
9.1%
1/11 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
50.0%
4/8 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
4.3%
1/23 • Number of events 1 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
12.5%
1/8 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
60.0%
3/5 • Number of events 6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
33.3%
3/9 • Number of events 4 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/11 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/6 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/23 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
13.0%
3/23 • Number of events 3 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/8 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/5 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
0.00%
0/9 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, up to 25 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, up to 25 months.
All-Cause Mortality was assessed for the Full Analysis Set. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were assessed for the Safety Population (all participants that received at least one dose of NUC-3373).
|
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