Trial Outcomes & Findings for Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma (NCT NCT03654833)
NCT ID: NCT03654833
Last Updated: 2026-08-17
Results Overview
This will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death-whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
186 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-08-17
Participant Flow
The MiST Master protocol states "Trial Design of the MiST study is in three stages: Stage 1-molecular pre-screening: The MiST Master protocol describes the identification of patients, biomarker testing and analysis. Stage 2- Treatment: The MiST treatment protocol will be specific to the treatment allocated to the patient Stage 3-Genomic Profiling": The Screening target for the pre-screening stage was 186 patients. After screening the number recruited for the treatment stage was 130 patients.
Participant milestones
| Measure |
MiST-1
Rucaparib in DNA damage sensitive relapsed mesothelioma. 600mg twice daily (BID) every 28 days. Tablet. Oral use.
|
MiST-2
Abemaciclib in p16INK4A negative mesothelioma. 200mg twice daily (BID) for 28 days. Capsule. Oral use.
|
MiST-3
Pembrolizumab and bemcentinib in relapsed mesothelioma. Bemcentinib will be administered once daily. On first 3 days of administration the dose will be a loading of 400mg. From Day 4 onwards, patients will receive a daily dose of 200mg. Each cycle will be 21 days.
Pembrolizumab will be given at a fixed dose of 200mg via IV infusion on Day 1 of each 21-day cycle.
Each drug will be administered for up to 35 cycles or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Injection, Capsule. Intravenous use, Oral use.
|
MiST-4
Atezolizumab and Bevacizumab in relapsed mesothelioma. Atezolizumab will be given as a fixed dose of 1200mg via IV infusion on day 1 of a 21-day cycle.
Bevacizumab will be given as 15 mg/kg via IV infusion on Days 1 of a 21-day cycle.
Infusion. Intravenous use.
|
MiST-5
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma.
Niraparib will be administered once daily depending on patient's weight and platelet count. A cycle consist of 21 days and there will be up to 35 cycles in total: • ≥77 kg and ≥150,000 μL 300 mg (3 X 100 mg capsules) • \<77 kg or \<150,000 μL 200 mg (2 X 100 mg capsules) Dostarlimab will be given at a fixed dose of 500mg via IV infusion on Day 1 of each 21-day cycle for 4 cycles. Followed by 1000mg via IV infusion on Day 1 of each 42-day cycle for up to 24 months. • Each will be administered for up to 24 months or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Capsule, Infusion. Oral use, Intravenous use.
|
|---|---|---|---|---|---|
|
12 Weeks
COMPLETED
|
18
|
14
|
18
|
18
|
21
|
|
12 Weeks
NOT COMPLETED
|
8
|
12
|
8
|
8
|
5
|
|
Baseline
STARTED
|
26
|
26
|
26
|
26
|
26
|
|
Baseline
COMPLETED
|
26
|
26
|
26
|
26
|
26
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
12 Weeks
STARTED
|
26
|
26
|
26
|
26
|
26
|
|
24 Weeks
STARTED
|
18
|
14
|
18
|
18
|
21
|
|
24 Weeks
COMPLETED
|
10
|
7
|
10
|
9
|
11
|
|
24 Weeks
NOT COMPLETED
|
8
|
7
|
8
|
9
|
10
|
Reasons for withdrawal
| Measure |
MiST-1
Rucaparib in DNA damage sensitive relapsed mesothelioma. 600mg twice daily (BID) every 28 days. Tablet. Oral use.
|
MiST-2
Abemaciclib in p16INK4A negative mesothelioma. 200mg twice daily (BID) for 28 days. Capsule. Oral use.
|
MiST-3
Pembrolizumab and bemcentinib in relapsed mesothelioma. Bemcentinib will be administered once daily. On first 3 days of administration the dose will be a loading of 400mg. From Day 4 onwards, patients will receive a daily dose of 200mg. Each cycle will be 21 days.
Pembrolizumab will be given at a fixed dose of 200mg via IV infusion on Day 1 of each 21-day cycle.
Each drug will be administered for up to 35 cycles or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Injection, Capsule. Intravenous use, Oral use.
|
MiST-4
Atezolizumab and Bevacizumab in relapsed mesothelioma. Atezolizumab will be given as a fixed dose of 1200mg via IV infusion on day 1 of a 21-day cycle.
Bevacizumab will be given as 15 mg/kg via IV infusion on Days 1 of a 21-day cycle.
Infusion. Intravenous use.
|
MiST-5
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma.
Niraparib will be administered once daily depending on patient's weight and platelet count. A cycle consist of 21 days and there will be up to 35 cycles in total: • ≥77 kg and ≥150,000 μL 300 mg (3 X 100 mg capsules) • \<77 kg or \<150,000 μL 200 mg (2 X 100 mg capsules) Dostarlimab will be given at a fixed dose of 500mg via IV infusion on Day 1 of each 21-day cycle for 4 cycles. Followed by 1000mg via IV infusion on Day 1 of each 42-day cycle for up to 24 months. • Each will be administered for up to 24 months or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Capsule, Infusion. Oral use, Intravenous use.
|
|---|---|---|---|---|---|
|
12 Weeks
Physician Decision
|
1
|
2
|
0
|
0
|
0
|
|
12 Weeks
Death
|
0
|
2
|
3
|
3
|
0
|
|
12 Weeks
Lack of Efficacy
|
6
|
6
|
4
|
5
|
5
|
|
12 Weeks
Toxicity
|
1
|
1
|
0
|
0
|
0
|
|
12 Weeks
Patient Choice
|
0
|
1
|
0
|
0
|
0
|
|
12 Weeks
Did not attend 12 week CT scan
|
0
|
0
|
1
|
0
|
0
|
|
24 Weeks
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
24 Weeks
Missed 24 week visit
|
0
|
1
|
0
|
0
|
0
|
|
24 Weeks
Death
|
0
|
1
|
4
|
1
|
3
|
|
24 Weeks
Patient Choice
|
0
|
1
|
0
|
0
|
0
|
|
24 Weeks
Lack of Efficacy
|
8
|
4
|
4
|
8
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MiST-5
n=26 Participants
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma
|
Total
n=130 Participants
Total of all reporting groups
|
MiST-1
n=26 Participants
Rucaparib in DNA damage sensitive relapsed mesothelioma
|
MiST-2
n=26 Participants
Abemaciclib in p16INK4A negative mesothelioma
|
MiST-3
n=26 Participants
Pembrolizumab and bemcentinib in relapsed mesothelioma
|
MiST-4
n=26 Participants
Atezolizumab and Bevacizumab in relapsed mesothelioma
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.5 years
n=26 Participants
|
69.0 years
n=130 Participants
|
66.5 years
n=26 Participants
|
67.5 years
n=26 Participants
|
72.5 years
n=26 Participants
|
68.0 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=26 Participants
|
23 Participants
n=130 Participants
|
4 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=26 Participants
|
107 Participants
n=130 Participants
|
22 Participants
n=26 Participants
|
23 Participants
n=26 Participants
|
23 Participants
n=26 Participants
|
18 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
—
|
—
|
—
|
|
Mesothelioma subtype
Epithelioid
|
21 Participants
n=26 Participants
|
106 Participants
n=130 Participants
|
21 Participants
n=26 Participants
|
21 Participants
n=26 Participants
|
23 Participants
n=26 Participants
|
20 Participants
n=26 Participants
|
|
Mesothelioma subtype
Biphasic
|
1 Participants
n=26 Participants
|
14 Participants
n=130 Participants
|
5 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
|
Mesothelioma subtype
Sarcomatoid
|
2 Participants
n=26 Participants
|
6 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
|
Mesothelioma subtype
NOS
|
2 Participants
n=26 Participants
|
4 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
|
Smoking status
Smoker
|
4 Participants
n=26 Participants
|
11 Participants
n=130 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
|
Smoking status
Non-smoker
|
12 Participants
n=26 Participants
|
66 Participants
n=130 Participants
|
15 Participants
n=26 Participants
|
14 Participants
n=26 Participants
|
12 Participants
n=26 Participants
|
13 Participants
n=26 Participants
|
|
Smoking status
Ex-smoker
|
10 Participants
n=26 Participants
|
53 Participants
n=130 Participants
|
9 Participants
n=26 Participants
|
10 Participants
n=26 Participants
|
13 Participants
n=26 Participants
|
11 Participants
n=26 Participants
|
|
History of asbestos
Yes
|
18 Participants
n=26 Participants
|
89 Participants
n=130 Participants
|
15 Participants
n=26 Participants
|
20 Participants
n=26 Participants
|
20 Participants
n=26 Participants
|
16 Participants
n=26 Participants
|
|
History of asbestos
No
|
0 Participants
n=26 Participants
|
6 Participants
n=130 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
|
History of asbestos
Unknown
|
8 Participants
n=26 Participants
|
35 Participants
n=130 Participants
|
9 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
6 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
|
ECOG status
Zero
|
2 Participants
n=26 Participants
|
20 Participants
n=130 Participants
|
4 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
6 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
|
ECOG status
One
|
24 Participants
n=26 Participants
|
110 Participants
n=130 Participants
|
22 Participants
n=26 Participants
|
22 Participants
n=26 Participants
|
20 Participants
n=26 Participants
|
22 Participants
n=26 Participants
|
|
Primary Tumour site
Missing
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Number of prior courses of systemic anticancer therapy
Five
|
0 Participants
n=26 Participants
|
3 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
|
Primary Tumour site
Thoracic
|
24 Participants
n=26 Participants
|
124 Participants
n=130 Participants
|
25 Participants
n=26 Participants
|
26 Participants
n=26 Participants
|
25 Participants
n=26 Participants
|
24 Participants
n=26 Participants
|
|
Primary Tumour site
Abdominal
|
2 Participants
n=26 Participants
|
4 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
|
P16
Negative
|
0 Participants
n=26 Participants
|
46 Participants
n=130 Participants
|
20 Participants
n=26 Participants
|
26 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Primary Tumour site
Pelvis
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
|
T-stage
T1
|
6 Participants
n=26 Participants
|
20 Participants
n=130 Participants
|
3 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
|
T-stage
T2
|
4 Participants
n=26 Participants
|
21 Participants
n=130 Participants
|
3 Participants
n=26 Participants
|
9 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
|
T-stage
T3
|
6 Participants
n=26 Participants
|
37 Participants
n=130 Participants
|
10 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
9 Participants
n=26 Participants
|
7 Participants
n=26 Participants
|
|
T-stage
T4
|
8 Participants
n=26 Participants
|
44 Participants
n=130 Participants
|
9 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
6 Participants
n=26 Participants
|
13 Participants
n=26 Participants
|
|
T-stage
Missing
|
1 Participants
n=26 Participants
|
2 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
T-stage
TX
|
0 Participants
n=26 Participants
|
3 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
|
T-stage
Unobtainable
|
1 Participants
n=26 Participants
|
3 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
N-stage
N0
|
13 Participants
n=26 Participants
|
59 Participants
n=130 Participants
|
9 Participants
n=26 Participants
|
10 Participants
n=26 Participants
|
16 Participants
n=26 Participants
|
11 Participants
n=26 Participants
|
|
N-stage
N1
|
7 Participants
n=26 Participants
|
33 Participants
n=130 Participants
|
6 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
6 Participants
n=26 Participants
|
6 Participants
n=26 Participants
|
|
N-stage
N2
|
2 Participants
n=26 Participants
|
27 Participants
n=130 Participants
|
7 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
|
N-stage
N3
|
2 Participants
n=26 Participants
|
6 Participants
n=130 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
|
N-stage
Missing
|
1 Participants
n=26 Participants
|
2 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
N-stage
Unobtainable
|
1 Participants
n=26 Participants
|
3 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
M-stage
M0
|
16 Participants
n=26 Participants
|
97 Participants
n=130 Participants
|
21 Participants
n=26 Participants
|
21 Participants
n=26 Participants
|
19 Participants
n=26 Participants
|
20 Participants
n=26 Participants
|
|
M-stage
M1
|
6 Participants
n=26 Participants
|
26 Participants
n=130 Participants
|
4 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
6 Participants
n=26 Participants
|
|
M-stage
Missing
|
1 Participants
n=26 Participants
|
2 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
M-stage
Unobtainable
|
3 Participants
n=26 Participants
|
5 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
P16
Positive
|
0 Participants
n=26 Participants
|
6 Participants
n=130 Participants
|
6 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
P16
Not applicable
|
26 Participants
n=26 Participants
|
78 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
26 Participants
n=26 Participants
|
26 Participants
n=26 Participants
|
|
Number of prior courses of systemic anticancer therapy
One
|
20 Participants
n=26 Participants
|
71 Participants
n=130 Participants
|
12 Participants
n=26 Participants
|
10 Participants
n=26 Participants
|
17 Participants
n=26 Participants
|
12 Participants
n=26 Participants
|
|
Number of prior courses of systemic anticancer therapy
Two
|
6 Participants
n=26 Participants
|
34 Participants
n=130 Participants
|
6 Participants
n=26 Participants
|
7 Participants
n=26 Participants
|
7 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
|
Number of prior courses of systemic anticancer therapy
Three
|
0 Participants
n=26 Participants
|
17 Participants
n=130 Participants
|
6 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
|
Number of prior courses of systemic anticancer therapy
Four
|
0 Participants
n=26 Participants
|
5 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed/Carboplatin
|
0 Participants
n=26 Participants
|
7 Participants
n=130 Participants
|
7 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed/Cisplatin
|
0 Participants
n=26 Participants
|
3 Participants
n=130 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed & Carboplatin
|
17 Participants
n=26 Participants
|
26 Participants
n=130 Participants
|
9 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed & Cisplatin
|
3 Participants
n=26 Participants
|
6 Participants
n=130 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed & Cisplatin & Bevacizumab
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Other
|
0 Participants
n=26 Participants
|
2 Participants
n=130 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed and/or Carboplatin
|
0 Participants
n=26 Participants
|
44 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
17 Participants
n=26 Participants
|
11 Participants
n=26 Participants
|
16 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed and/or Cisplatin
|
0 Participants
n=26 Participants
|
21 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
|
First line therapy
Radiotherapy
|
0 Participants
n=26 Participants
|
2 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed and Cisplatin/Carboplatin
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Bevacizumab and Pemetrexed and/or Carboplatin
|
1 Participants
n=26 Participants
|
6 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Bevacizumab alone
|
1 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Pemetrexed alone
|
1 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
First line therapy
Missing
|
3 Participants
n=26 Participants
|
9 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed/Carboplatin
|
0 Participants
n=26 Participants
|
4 Participants
n=130 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed/Cisplatin
|
0 Participants
n=26 Participants
|
2 Participants
n=130 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed & Carboplatin
|
0 Participants
n=26 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed & Cisplatin
|
0 Participants
n=26 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed & Cisplatin & Bevacizumab
|
0 Participants
n=26 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Other
|
0 Participants
n=26 Participants
|
8 Participants
n=130 Participants
|
6 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed and/or Carboplatin
|
2 Participants
n=26 Participants
|
13 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
5 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed and/or Cisplatin
|
0 Participants
n=26 Participants
|
4 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
|
Second line therapy
Rucaparib
|
0 Participants
n=26 Participants
|
2 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Nivolumab/Placebo
|
0 Participants
n=26 Participants
|
4 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Vinorelbine
|
0 Participants
n=26 Participants
|
6 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
|
Second line therapy
Gemcitabine & AZD6738
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Pemetrexed/Carboplatin and Bevacizumab
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Bevacizumab
|
1 Participants
n=26 Participants
|
3 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Vinorelbine & carboplatin
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Radiotherapy
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
ADI-Peg 20/placebo
|
1 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
RSO-1
|
1 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Carboplatin and taxel
|
1 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Pembrolizumab + Defactinid
|
0 Participants
n=26 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
|
Second line therapy
Missing
|
20 Participants
n=26 Participants
|
76 Participants
n=130 Participants
|
13 Participants
n=26 Participants
|
10 Participants
n=26 Participants
|
17 Participants
n=26 Participants
|
16 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThis will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death-whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
Outcome measures
| Measure |
MiST-1
n=26 Participants
Rucaparib in DNA damage sensitive relapsed mesothelioma
|
MiST-2
n=26 Participants
Abemaciclib in p16INK4A negative mesothelioma
|
MiST-3
n=26 Participants
Pembrolizumab and bemcentinib in relapsed mesothelioma
|
MiST-4
n=26 Participants
Atezolizumab and Bevacizumab in relapsed mesothelioma
|
MiST-5
n=26 Participants
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR) at 12 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.
|
15 Participants
|
14 Participants
|
12 Participants
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 24 weeksThis will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death - whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
Outcome measures
| Measure |
MiST-1
n=26 Participants
Rucaparib in DNA damage sensitive relapsed mesothelioma
|
MiST-2
n=26 Participants
Abemaciclib in p16INK4A negative mesothelioma
|
MiST-3
n=26 Participants
Pembrolizumab and bemcentinib in relapsed mesothelioma
|
MiST-4
n=26 Participants
Atezolizumab and Bevacizumab in relapsed mesothelioma
|
MiST-5
n=26 Participants
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.
|
6 Participants
|
6 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 24 weeksThis will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death - whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
Outcome measures
| Measure |
MiST-1
n=26 Participants
Rucaparib in DNA damage sensitive relapsed mesothelioma
|
MiST-2
n=26 Participants
Abemaciclib in p16INK4A negative mesothelioma
|
MiST-3
n=26 Participants
Pembrolizumab and bemcentinib in relapsed mesothelioma
|
MiST-4
n=26 Participants
Atezolizumab and Bevacizumab in relapsed mesothelioma
|
MiST-5
n=26 Participants
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
MiST-1
Serious events: 9 serious events
Other events: 24 other events
Deaths: 12 deaths
MiST-2
Serious events: 6 serious events
Other events: 22 other events
Deaths: 12 deaths
MiST-3
Serious events: 10 serious events
Other events: 24 other events
Deaths: 16 deaths
MiST-4
Serious events: 11 serious events
Other events: 23 other events
Deaths: 7 deaths
MiST-5
Serious events: 9 serious events
Other events: 22 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
MiST-1
n=26 participants at risk
Rucaparib in DNA damage sensitive relapsed mesothelioma
|
MiST-2
n=26 participants at risk
Abemaciclib in p16INK4A negative mesothelioma
|
MiST-3
n=26 participants at risk
Pembrolizumab and bemcentinib in relapsed mesothelioma
|
MiST-4
n=26 participants at risk
Atezolizumab and Bevacizumab in relapsed mesothelioma
|
MiST-5
n=26 participants at risk
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma
|
|---|---|---|---|---|---|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Peripheral swelling
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Pyrexia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Lower respiratory tract infection
|
3.8%
1/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Hepatitis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Neutropenic sepsis
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Empyema
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Infection
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Sepsis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Encephalitis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Cardiac disorders
Pericardial effusion
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Nervous system disorders
Ischaemic stroke
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
Other adverse events
| Measure |
MiST-1
n=26 participants at risk
Rucaparib in DNA damage sensitive relapsed mesothelioma
|
MiST-2
n=26 participants at risk
Abemaciclib in p16INK4A negative mesothelioma
|
MiST-3
n=26 participants at risk
Pembrolizumab and bemcentinib in relapsed mesothelioma
|
MiST-4
n=26 participants at risk
Atezolizumab and Bevacizumab in relapsed mesothelioma
|
MiST-5
n=26 participants at risk
Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
6/26 • Number of events 9 • From enrolment up to at least 6 months follow-up
|
30.8%
8/26 • Number of events 14 • From enrolment up to at least 6 months follow-up
|
19.2%
5/26 • Number of events 12 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
19.2%
5/26 • Number of events 6 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 8 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Ascites
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Hypomagnesaemia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Constipation
|
23.1%
6/26 • Number of events 6 • From enrolment up to at least 6 months follow-up
|
23.1%
6/26 • Number of events 6 • From enrolment up to at least 6 months follow-up
|
26.9%
7/26 • Number of events 9 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
26.9%
7/26 • Number of events 7 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
26.9%
7/26 • Number of events 9 • From enrolment up to at least 6 months follow-up
|
50.0%
13/26 • Number of events 19 • From enrolment up to at least 6 months follow-up
|
26.9%
7/26 • Number of events 12 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Nausea
|
69.2%
18/26 • Number of events 21 • From enrolment up to at least 6 months follow-up
|
34.6%
9/26 • Number of events 11 • From enrolment up to at least 6 months follow-up
|
42.3%
11/26 • Number of events 12 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
34.6%
9/26 • Number of events 10 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
19.2%
5/26 • Number of events 7 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Acid reflux
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
|
Blood and lymphatic system disorders
Leg and/or ankle oedema
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Hepatobiliary disorders
Increased ALT
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Hepatobiliary disorders
Increased AST
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 6 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 7 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.5%
3/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 5 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Renal and urinary disorders
Raised creatinine
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
COVID-19
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Chest infection
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Gastrointestinal disorders
Oral candidiasis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Metabolism and nutrition disorders
Weight loss
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Infection
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.5%
10/26 • Number of events 11 • From enrolment up to at least 6 months follow-up
|
30.8%
8/26 • Number of events 9 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Chills
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Constipation
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Epistaxis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Investigations
Thrombocytopenia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Investigations
Raised creatinine
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 5 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Investigations
Weight loss
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Investigations
Increased ALT
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Investigations
Increased AST
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Sore mouth or throat
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Cold symptoms
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Fever
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
General pain
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Swollen legs and feet
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Abdominal pain
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Joint pain (Shoulder, hip and/or general)
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Nausea
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Decreased appetite
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
19.2%
5/26 • Number of events 5 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Dizziness
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Cough
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Neck or shoulder ache
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Chest infection
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Lethargy
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Restless leg syndrome
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Increased sweating
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Breathlessness
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
|
General disorders
COVID-19
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.8%
8/26 • Number of events 9 • From enrolment up to at least 6 months follow-up
|
23.1%
6/26 • Number of events 7 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
19.2%
5/26 • Number of events 5 • From enrolment up to at least 6 months follow-up
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Fatigue
|
53.8%
14/26 • Number of events 14 • From enrolment up to at least 6 months follow-up
|
61.5%
16/26 • Number of events 17 • From enrolment up to at least 6 months follow-up
|
46.2%
12/26 • Number of events 16 • From enrolment up to at least 6 months follow-up
|
30.8%
8/26 • Number of events 10 • From enrolment up to at least 6 months follow-up
|
46.2%
12/26 • Number of events 12 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Dry mouth
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Mouth ulceration
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Non cardiac chest pain
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
General disorders
Weight decreased
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
23.1%
6/26 • Number of events 6 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Non cardiac chest pain
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 2 • From enrolment up to at least 6 months follow-up
|
15.4%
4/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Parasthesia
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
7.7%
2/26 • Number of events 4 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
0.00%
0/26 • From enrolment up to at least 6 months follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
23.1%
6/26 • Number of events 8 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
3.8%
1/26 • Number of events 1 • From enrolment up to at least 6 months follow-up
|
11.5%
3/26 • Number of events 3 • From enrolment up to at least 6 months follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place