Trial Outcomes & Findings for A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer (NCT NCT04564027)
NCT ID: NCT04564027
Last Updated: 2025-08-29
Results Overview
ORR is defined as the percentage of participants who have at least one response of complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by response evaluation criteria in solid tumours \[RECIST\] 1.1) that is confirmed at least 4 weeks later. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
2 years 4 months
Results posted on
2025-08-29
Participant Flow
Participants were enrolled in this study from 01 December 2020 to 04 April 2023 at 18 centers in 3 countries.
The screening comprised of 2 parts, Part1 and Part 2, which applied for both Cohort A and Cohort B. Participants meeting the inclusion criteria were enrolled in the study. All the assessments were performed as per the schedule of the assessments.
Participant milestones
| Measure |
Cohort A (aST): 240 mg of Ceralasertib
Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 160 mg of Ceralasertib
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
30
|
1
|
15
|
|
Overall Study
COMPLETED
|
8
|
27
|
1
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A (aST): 240 mg of Ceralasertib
Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 160 mg of Ceralasertib
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Overall Study
Ongoing treatment at Data cut off
|
0
|
3
|
0
|
0
|
Baseline Characteristics
A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer
Baseline characteristics by cohort
| Measure |
Cohort A (aST): 240 mg of Ceralasertib
n=8 Participants
Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 160 mg of Ceralasertib
n=30 Participants
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
n=1 Participants
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
n=15 Participants
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
3 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
|
Age, Customized
65-84 years
|
5 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
12 Participants
n=31 Participants
|
37 Participants
n=146 Participants
|
|
Age, Customized
≥ 85 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
19 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
35 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiin or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
25 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
11 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
19 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
8 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
31 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 2 years 4 monthsPopulation: Evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed evaluable for response set with measurable disease at baseline and who received at least 1 dose of study intervention.
ORR is defined as the percentage of participants who have at least one response of complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by response evaluation criteria in solid tumours \[RECIST\] 1.1) that is confirmed at least 4 weeks later. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Outcome measures
| Measure |
Cohort A (aST): 160 mg of Ceralasertib
n=28 Participants
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 240 mg of Ceralasertib
Participants with ATM -altered aST received 240mg of ceralasertib from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Cohort A (aST): Objective Response Rate (ORR).
|
7.14 Percentage of participants
Interval 1.9 to 17.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 years 4 monthsPopulation: Evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed evaluable for response set with measurable disease at baseline or unfavorable CTC count and who received at least 1 dose of study intervention.
Composite response rate is defined as the investigator assessed radiological response by RECIST 1.1 for soft tissue and visceral lesions and Prostate Cancer Working Group 3 (PCWG3) for bone lesions, confirmed prostate specific antigen (PSA) decline of more than 50%, and/or confirmed circulating tumour cell \[CTC\] conversion from unfavorable (\>=5 cells/7.5 ml blood) to favorable (\<5 cells). Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Outcome measures
| Measure |
Cohort A (aST): 160 mg of Ceralasertib
n=13 Participants
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 240 mg of Ceralasertib
Participants with ATM -altered aST received 240mg of ceralasertib from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Cohort B (mCRPC): Composite Response Rate.
|
7.7 Percentage of participants
Interval 0.8 to 26.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years 4 monthsPopulation: Molecularly eligible centrally confirmed evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed with measurable baseline disease and who received at least 1 dose of study intervention. The number of responders who subsequently progressed or died was 0, therefore, efficacy analysis was not conducted for Duration of response (DoR).
DoR is defined as the time from the date of first documented response (confirmed CR/PR) until date of documented progression or death in the absence of disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years 4 monthsPopulation: Molecularly eligible centrally confirmed set included all participants who were Molecularly Eligible Centrally Confirmed and who received at least 1 dose of study intervention.
PFS is defined as the time from start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression. Progression is defined using (RECIST v1.0), 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. Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Outcome measures
| Measure |
Cohort A (aST): 160 mg of Ceralasertib
n=28 Participants
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 240 mg of Ceralasertib
Participants with ATM -altered aST received 240mg of ceralasertib from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Cohort A (aST): Progression Free Survival (PFS)
|
3.7 Months
Interval 1.9 to 5.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32), 5 (Week 40), 6 (Week (48), 7 (Week 56)Population: Molecularly eligible centrally confirmed evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed with measurable baseline disease and who received at least 1 dose of study intervention. Percentage change in tumor size was conducted every 8 weeks after the start of the treatment up to 1 year, then every 12 weeks until objective disease progression as per RECIST 1.1 or PCWG3 criteria.
Percentage change in tumour size is defined as the reduction from baseline or the increase from baseline in the absence of a reduction in the sum of the longest diameters (or the short axis measurements for lymph nodes) of the target lesions. A negative change denotes a reduction in target lesion size.
Outcome measures
| Measure |
Cohort A (aST): 160 mg of Ceralasertib
n=28 Participants
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 240 mg of Ceralasertib
n=5 Participants
Participants with ATM -altered aST received 240mg of ceralasertib from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Cohort A (aST): Percentage Change in Tumor Size
Scan Visit 1 (Week 8)
|
6.6 Percentage change
Standard Deviation 22.45
|
6.2 Percentage change
Standard Deviation 10.99
|
—
|
—
|
|
Cohort A (aST): Percentage Change in Tumor Size
Scan Visit 2 (Week 16)
|
-4.7 Percentage change
Standard Deviation 16.83
|
5.4 Percentage change
Standard Deviation NA
Since there is only 1 participant with target lesion, descriptive statistics like Standard deviation cannot be calculated.
|
—
|
—
|
|
Cohort A (aST): Percentage Change in Tumor Size
Scan Visit 3 (Week 24)
|
-12.8 Percentage change
Standard Deviation 21.47
|
—
|
—
|
—
|
|
Cohort A (aST): Percentage Change in Tumor Size
Scan Visit 4 (Week 32)
|
-17.9 Percentage change
Standard Deviation 34.41
|
—
|
—
|
—
|
|
Cohort A (aST): Percentage Change in Tumor Size
Scan Visit 5 (Week 40)
|
-1.1 Percentage change
Standard Deviation NA
Since there is only 1 participant with target lesion, descriptive statistics like Standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
Cohort A (aST): Percentage Change in Tumor Size
Scan Visit 6 (Week 48)
|
-100 Percentage change
Standard Deviation NA
Since there is only 1 participant with target lesion, descriptive statistics like Standard deviation cannot be calculated.
|
—
|
—
|
—
|
|
Cohort A (aST): Percentage Change in Tumor Size
Scan Visit 7 (Week 56)
|
-100 Percentage change
Standard Deviation NA
Since there is only 1 participant with target lesion, descriptive statistics like Standard deviation cannot be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32)Population: Molecularly eligible centrally confirmed evaluable for response set included all participants who were Molecularly Eligible Centrally Confirmed with measurable baseline disease and who received at least 1 dose of study intervention. Percentage change in tumor size was conducted every 8 weeks after the start of the treatment up to 1 year, then every 12 weeks until objective disease progression as per RECIST 1.1 or PCWG3 criteria.
Percentage change in tumour size is defined as the reduction from baseline or the increase from baseline in the absence of a reduction in the sum of the longest diameters (or the short axis measurements for lymph nodes) of the target lesions. A negative change denotes a reduction in target lesion size. Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Outcome measures
| Measure |
Cohort A (aST): 160 mg of Ceralasertib
n=11 Participants
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 240 mg of Ceralasertib
Participants with ATM -altered aST received 240mg of ceralasertib from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Cohort B (mRCPC): Percentage Change in Tumor Size
Scan Visit 1 (Week 8)
|
2.0 Percentage change
Standard Deviation 21.35
|
—
|
—
|
—
|
|
Cohort B (mRCPC): Percentage Change in Tumor Size
Scan Visit 2 (Week 16)
|
-6.0 Percentage change
Standard Deviation 9.37
|
—
|
—
|
—
|
|
Cohort B (mRCPC): Percentage Change in Tumor Size
Scan Visit 3 (Week 24)
|
-1.4 Percentage change
Standard Deviation 11.75
|
—
|
—
|
—
|
|
Cohort B (mRCPC): Percentage Change in Tumor Size
Scan Visit 4 (Week 32)
|
-5.2 Percentage change
Standard Deviation 13.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 monthsPopulation: The safety analysis consists of all the participants who received at least 1 dose of ceralasterib.
The adverse events as a variable of safety and tolerability after admiration of ceralasertib was determined.
Outcome measures
| Measure |
Cohort A (aST): 160 mg of Ceralasertib
n=8 Participants
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 240 mg of Ceralasertib
n=30 Participants
Participants with ATM -altered aST received 240mg of ceralasertib from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
n=1 Participants
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
n=15 Participants
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
All Adverse events (AE)
|
8 Participants
|
30 Participants
|
1 Participants
|
15 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE possibly related to treatment
|
8 Participants
|
21 Participants
|
1 Participants
|
13 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE of CTCAE Grade 3 or higher
|
6 Participants
|
15 Participants
|
1 Participants
|
8 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE of CTCAE Grade 3 or higher, possibly related to IP
|
4 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE with outcome of death
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE with outcome = death, possibly related to IP
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any SAE (including events with outcome = death)
|
6 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any SAE (including events with outcome = death), possibly related to IP
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any SAE leading to discontinuation of IP
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any SAE leading to discontinuation of IP, possibly related to IP
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE leading to discontinuation of IP
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE leading to discontinuation of IP, possibly related to IP
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE leading to dose modification
|
4 Participants
|
10 Participants
|
1 Participants
|
5 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE leading to dose reduction
|
1 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE leading to dose interruption
|
4 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any AE leading to dosing cycle delays
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Any other significant AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort A (aST): 240 mg of Ceralasertib
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort A (aST): 160 mg of Ceralasertib
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Cohort B (mCRPC): 240 mg of Ceralasertib
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Cohort B (mCRPC): 160 mg of Ceralasertib
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (aST): 240 mg of Ceralasertib
n=8 participants at risk
Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 160 mg of Ceralasertib
n=30 participants at risk
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
n=1 participants at risk
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
n=15 participants at risk
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Device related infection
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Platelet count decreased
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Cohort A (aST): 240 mg of Ceralasertib
n=8 participants at risk
Participants with Ataxia telangiectasia mutated (ATM) altered Advanced solid tumour (aST) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort A (aST): 160 mg of Ceralasertib
n=30 participants at risk
Participants with ATM-altered aST received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 240 mg of Ceralasertib
n=1 participants at risk
Participants with ATM-altered Metastatic castration-resistant prostate cancer (mCRPC) received 240 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
Cohort B (mCRPC): 160 mg of Ceralasertib
n=15 participants at risk
Participants with ATM-altered mCRPC received 160 mg of ceralasertib twice daily from Day 1 to Day 14 of 28 days cycle.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
23.3%
7/30 • Number of events 7 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
16.7%
5/30 • Number of events 9 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 4 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
30.0%
9/30 • Number of events 9 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Herpes simplex reactivation
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Skin infection
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Device related infection
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
6/8 • Number of events 8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
26.7%
8/30 • Number of events 10 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
40.0%
6/15 • Number of events 8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
20.0%
6/30 • Number of events 8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
20.0%
6/30 • Number of events 6 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
20.0%
3/15 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 4 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
4/30 • Number of events 8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dysguesia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dysarthria
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Periorbital oedema
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Scleral haemorrhage
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Palpitation
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
4/8 • Number of events 5 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
4/30 • Number of events 5 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 5 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
43.3%
13/30 • Number of events 14 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
53.3%
8/15 • Number of events 10 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
16.7%
5/30 • Number of events 5 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
16.7%
5/30 • Number of events 6 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 5 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
4/30 • Number of events 7 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Platelet count decreased
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 4 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Platelet count increased
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
White blood cell count decreased
|
37.5%
3/8 • Number of events 4 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
10.0%
3/30 • Number of events 3 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
2/30 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
23.3%
7/30 • Number of events 7 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
13.3%
2/15 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest pain
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Facial pain
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 4 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
26.7%
8/30 • Number of events 8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
33.3%
5/15 • Number of events 5 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
oedema peripheral
|
25.0%
2/8 • Number of events 2 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
3.3%
1/30 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/15 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Mucosal discolouration
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/8 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/30 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
6.7%
1/15 • Number of events 1 • From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Safety analysis consist of all participants who received at least 1 dose of study intervention.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB. Access to this document must be restricted to relevant parties.
- Publication restrictions are in place
Restriction type: OTHER