Trial Outcomes & Findings for A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors (NCT NCT05572684)
NCT ID: NCT05572684
Last Updated: 2026-08-13
Results Overview
Number of Participants With Treatment-emergent Adverse Events
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
97 participants
Primary outcome timeframe
From enrollment through up to 90 days after end of treatment, an average of 1 year
Results posted on
2026-08-13
Participant Flow
97 participants took part in the study at 17 investigative sites from 06Oct2022 to 30Apr2023.
Phase 1b (Dose Escalation) consisted of 4 planned cohorts evaluating NC410 IV doses ranging from 30 mg to 200 mg in combination with 400 mg pembrolizumab. A total of 97 participants were enrolled in Phase 1b between 06Oct2022 and 30Apr2023. Following completion of the Phase 1b portion, the sponsor decided not to initiate the planned Phase 2 portion of the study. No participants were enrolled in Phase 2.
Participant milestones
| Measure |
NC410 30mg and Pembrolizumab
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
200mg of NC410 and Pembrolizumab
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
11
|
65
|
18
|
|
Overall Study
COMPLETED
|
1
|
7
|
46
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
19
|
3
|
Reasons for withdrawal
| Measure |
NC410 30mg and Pembrolizumab
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
200mg of NC410 and Pembrolizumab
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
3
|
10
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
8
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
30mg NC410 and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
200mg NC410 and Pembrolizumab
n=18 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 6.03 • n=1 Participants
|
51.3 years
STANDARD_DEVIATION 11.14 • n=1 Participants
|
61.8 years
STANDARD_DEVIATION 9.38 • n=1 Participants
|
57.0 years
STANDARD_DEVIATION 12.53 • n=2 Participants
|
59.7 years
STANDARD_DEVIATION 10.62
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
34 Participants
n=1 Participants
|
13 Participants
n=2 Participants
|
55 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
31 Participants
n=1 Participants
|
5 Participants
n=2 Participants
|
42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
3 Participants
n=2 Participants
|
14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
57 Participants
n=1 Participants
|
15 Participants
n=2 Participants
|
83 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
9 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
53 Participants
n=1 Participants
|
14 Participants
n=2 Participants
|
77 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
6 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=1 Participants
|
11 participants
n=1 Participants
|
65 participants
n=1 Participants
|
18 participants
n=2 Participants
|
97 participants
|
|
Weight
|
94.07 kg
STANDARD_DEVIATION 19.202 • n=1 Participants
|
81.79 kg
STANDARD_DEVIATION 26.931 • n=1 Participants
|
80.58 kg
STANDARD_DEVIATION 20.366 • n=1 Participants
|
81.41 kg
STANDARD_DEVIATION 18.663 • n=2 Participants
|
81.30 kg
STANDARD_DEVIATION 20.667
|
PRIMARY outcome
Timeframe: From enrollment through up to 90 days after end of treatment, an average of 1 yearPopulation: The Safety Analysis Set (SAS) will include all the subjects who receive any amount of study drug.
Number of Participants With Treatment-emergent Adverse Events
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=18 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
|
18 Participants
|
3 Participants
|
11 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: until disease progression, up to 24 monthsPopulation: The full analysis set (FAS) includes all participants enrolled in the study who received at least one full dose of pembrolizumab and one full dose of NC410.
To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=18 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
2 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: until disease progression or death, up to 24 monthsPopulation: The full analysis set (FAS) includes all participants enrolled in the study who received at least one full dose of pembrolizumab and one full dose of NC410.
To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Subjects who are alive and progression free as of the analysis cut-off date, who discontinued the treatment or switched to a new treatment will be censored at their last evaluable tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: CompleteResponse (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=18 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: until disease progression, up to 24 monthsPopulation: The full analysis set (FAS) includes all participants enrolled in the study who received at least one full dose of pembrolizumab and one full dose of NC410.
To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response (lasting 24weeks or longer) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=18 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Disease Control Rate Per RECIST v1.1
|
3 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: until disease progression, up to 24 monthsPopulation: The full analysis set (FAS) includes all participants enrolled in the study who received at least one full dose of pembrolizumab and one full dose of NC410.
To evaluate progression-free survival (PFS), defined as time (in months) from starting study treatment to the first documented progressive disease or death due to any cause, whichever occurs first. Progressive disease will include both 'Progressive Disease' and 'Clinical Signs and Symptoms Consistent with Progressive Disease' from the RECIST CRFs. For participants who are alive and progression free at the time of discontinuation from study, data cutoff for analysis, or use of other anticancer drug, PFS will be censored at the last tumor assessment date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=18 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
2.2 months
Interval 2.0 to 4.9
|
1.8 months
Interval 1.4 to
The upper limit of the confidence interval were not estimable due to limited number of participants with events.
|
2.1 months
Interval 1.8 to 2.6
|
2.2 months
Interval 2.1 to 4.1
|
SECONDARY outcome
Timeframe: From start of study treatment until death due to any cause or censoring at the last known alive date, assessed up to 24 months.Population: The full analysis set (FAS) includes all participants enrolled in the study who received at least one full dose of pembrolizumab and one full dose of NC410.
Overall Survival, estimated using Kaplan-Meier, is defined as time in months from start of study treatment to death due to any cause. Subjects who were alive at the time of discontinuation from study or data cutoff for analysis were censored at their last known alive (LKA) date.
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=18 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
14.6 months
Interval 6.3 to
The upper limit of the confidence interval was not estimable due to limited number of participants with event.
|
27.3 months
The confidence interval bounds for the median overall survival estimate in the 30 mg NC410 and pembrolizumab arm were not estimable due to the limited number of events and small sample size, although the median overall survival value was estimable from the Kaplan-Meier analysis.
|
8.2 months
Interval 2.7 to 8.8
|
14.1 months
Interval 9.5 to
The upper limit of the confidence interval was not estimable due to limited number of participants with event.
|
SECONDARY outcome
Timeframe: PK samples collected pre-dose, 30 minutes post-NC410 infusion (end of infusion) on Day 1, 24 hours post-infusion on Day 2, at any time on Day 8 and pre-dose sample on Day 15Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis.
Maximum observed NC410 serum concentration at Cycle 1. Note participants enrolled at 200mg dose level were dosed with 100mg of NC410 at Cycle 1 Day 1.
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=17 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of NC410
|
2030 ng/mL
Standard Deviation 936
|
456 ng/mL
Standard Deviation 126
|
1070 ng/mL
Standard Deviation 375
|
2080 ng/mL
Standard Deviation 803
|
SECONDARY outcome
Timeframe: PK samples collected pre-dose, 30 minutes post-NC410 infusion (end of infusion) on Day 1, 24 hours post-infusion on Day 2, at any time on Day 8 and pre-dose sample on Day 15Population: The PK analysis set includes participants who received NC410 and had sufficient concentration-time data to estimate terminal half-life (t1/2) using noncompartmental analysis.
Terminal elimination half-life, in hours, calculated as 0.693/λz after each dose administration at Cycle 1. Note partipants enrolled at 200mg dose level were dosed with 100mg of NC410 at Cycle 1 Day 1.
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=11 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=1 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=9 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=37 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of NC410
|
128 h
Standard Deviation 23.1
|
116 h
No standard deviation value estimated because calculation impossible or highly unreliable due to low sample size.
|
126 h
Standard Deviation 21.5
|
128 h
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: Time of dosing to the time of the last measurable PK concentration at Cycle 1 Day 1. Samples taken pre-dose and 30-min post dose at Cycle 1 Day 1.Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis.
Area under the curve from the time of dosing to the time of the last measurable concentration at Cycle 1 Day 1.
Outcome measures
| Measure |
200mg of NC410 and Pembrolizumab
n=17 Participants
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
NC410 30mg and Pembrolizumab
n=3 Participants
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 Participants
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 Participants
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve (AUC) of NC410
|
130000 h*ng/mL
Standard Deviation 47700
|
32100 h*ng/mL
Standard Deviation 6520
|
67000 h*ng/mL
Standard Deviation 21900
|
124000 h*ng/mL
Standard Deviation 35600
|
Adverse Events
NC410 30mg and Pembrolizumab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
60mg of NC410 and Pembrolizumab
Serious events: 7 serious events
Other events: 11 other events
Deaths: 3 deaths
100mg of NC410 and Pembrolizumab
Serious events: 25 serious events
Other events: 62 other events
Deaths: 10 deaths
200mg of NC410 and Pembrolizumab
Serious events: 4 serious events
Other events: 18 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
NC410 30mg and Pembrolizumab
n=3 participants at risk
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 participants at risk
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 participants at risk
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
200mg of NC410 and Pembrolizumab
n=18 participants at risk
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
3.1%
2/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
12.3%
8/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
3.1%
2/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Psychiatric disorders
Mental status changes
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
4.6%
3/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
1.5%
1/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
Other adverse events
| Measure |
NC410 30mg and Pembrolizumab
n=3 participants at risk
30mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
60mg of NC410 and Pembrolizumab
n=11 participants at risk
60mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
100mg of NC410 and Pembrolizumab
n=65 participants at risk
100mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
200mg of NC410 and Pembrolizumab
n=18 participants at risk
200mg of NC410 for IV infusion administered in 14 day dosing cycles along with 400mg of pembrolizumab for IV infusion administered in 6 week dosing cycles.
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
7.7%
5/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Eye disorders
Eye disorder
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.2%
6/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
16.7%
3/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
32.3%
21/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
44.4%
8/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
7.7%
5/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
38.5%
25/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
22.2%
4/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
13.8%
9/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
36.4%
4/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
12.3%
8/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
22.2%
4/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
7.7%
5/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Chills
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
12.3%
8/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
7.7%
5/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
21.5%
14/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
16.7%
3/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
7.7%
5/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
12.3%
8/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.2%
6/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
12.3%
8/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
10.8%
7/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
13.8%
9/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
15.4%
10/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
22.2%
4/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.2%
6/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
13.8%
9/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
36.4%
4/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
10.8%
7/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
22.2%
4/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
10.8%
7/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Psychiatric disorders
Enuresis
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.2%
2/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
20.0%
13/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
27.3%
3/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
18.5%
12/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
11.1%
2/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
10.8%
7/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
16.7%
3/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
6.2%
4/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Skin and subcutaneous tissue disorders
Scab
|
33.3%
1/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
9.1%
1/11 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
0.00%
0/65 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
5.6%
1/18 • Serious and other adverse events were assessed from the time of informed consent through 90 days after the end of treatment. All-cause mortality was monitored throughout survival follow-up until patient death or withdraw of consent, up to approximately 27.3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot publish study results before the first multi-center publication. If a multi-center publication is not submitted within 12 months after the end of the study at all sites, or if Sponsor confirms there will be no multi-center publication, the PI may publish study results. However, PI will allow Sponsor at least 30 days to review any publication of study results and Sponsor may request an additional 60 days to review the publication.
- Publication restrictions are in place
Restriction type: OTHER