Trial Outcomes & Findings for Olaparib in People With Malignant Mesothelioma (NCT NCT03531840)

Last Updated: 2021-04-09

Results Overview

Number of participants overall who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

6 months after enrollment of last patient

Results posted on

2021-04-09

Participant Flow

Data is grouped as specified per protocol.

Participant milestones

Participant milestones
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups Participants With no tumor tissue available for somatic mutation
Overall Study STARTED	5	6	8	4
Overall Study COMPLETED	0	1	3	1
Overall Study NOT COMPLETED	5	5	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups Participants With no tumor tissue available for somatic mutation
Overall Study Death on study	3	2	1	2
Overall Study Death during follow up	2	3	4	1

Baseline Characteristics

Olaparib in People With Malignant Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=5 Participants Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations n=6 Participants Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations n=8 Participants Participants With no tumor tissue available for somatic mutation	Participants Not Classified Under Comparison Groups n=4 Participants Participants With no tumor tissue available for somatic mutation	Total n=23 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	3 participants n=4 Participants	21 participants n=21 Participants
Region of Enrollment Canada	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	13 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Age, Continuous	56.6 years STANDARD_DEVIATION 14.51 • n=5 Participants	61.82 years STANDARD_DEVIATION 10.71 • n=7 Participants	63.3 years STANDARD_DEVIATION 10.5 • n=5 Participants	65.3 years STANDARD_DEVIATION 4.19 • n=4 Participants	61.8 years STANDARD_DEVIATION 10.54 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	23 Participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months after enrollment of last patient

Population: Data is grouped as specified per protocol.

Outcome measures

Outcome measures
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=5 Participants Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations n=6 Participants Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations n=8 Participants Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups n=4 Participants Participants with no tumor tissue available for somatic mutation
Number of Participants With an Objective Response Partial Response	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With an Objective Response Complete Response	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 months after enrollment of last patient

Population: Per protocol, this outcome measure was only assessed in participants in Comparison Group 1.

Number of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Outcome measures

Outcome measures
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=5 Participants Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups Participants with no tumor tissue available for somatic mutation
Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response. Partial Response	1 Participants	—	—	—
Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response. Complete Response	0 Participants	—	—	—

PRIMARY outcome

Timeframe: 6 months after enrollment of last patient

Population: Per protocol, this outcome measure was only assessed in participants in Comparison Group 2.

Percentage of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Outcome measures

Outcome measures
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=6 Participants Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups Participants with no tumor tissue available for somatic mutation
Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response. Partial Response	0 percentage of participants	—	—	—
Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response. Complete Response	0 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: 6 months after enrollment of last patient

Population: Per protocol, this outcome measure was only assessed in participants in Comparison Group 3.

Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Outcome measures

Outcome measures
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=8 Participants Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups Participants with no tumor tissue available for somatic mutation
Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response. Partial Response	0 percentage of participants	—	—	—
Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response. Complete Response	0 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days.

Population: Data is grouped as specified per protocol.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=5 Participants Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations n=6 Participants Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations n=8 Participants Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups n=4 Participants Participants with no tumor tissue available for somatic mutation
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	5 Participants	6 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: 21 days after enrollment of last subject

Population: Data is grouped as specified per protocol.

Dose Limiting-toxicities (DLT's) is defined as

Outcome measures

Outcome measures
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=5 Participants Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations n=6 Participants Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations n=8 Participants Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations	Participants Not Classified Under Comparison Groups n=4 Participants Participants with no tumor tissue available for somatic mutation
Number of Participants With Dose Limiting-toxicities (DLT's)	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes

Serious events: 1 serious events

Other events: 5 other events

Deaths: 5 deaths

Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations

Serious events: 1 serious events

Other events: 8 other events

Deaths: 5 deaths

Participants Not Classified Under Comparison Groups

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes n=5 participants at risk Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes	Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations n=6 participants at risk Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations	Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations n=8 participants at risk Participants With no tumor tissue available for somatic mutation	Participants Not Classified Under Comparison Groups n=4 participants at risk Participants With no tumor tissue available for somatic mutation
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	33.3% 2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
Respiratory, thoracic and mediastinal disorders Aspiration	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
General disorders Disease progression	0.00% 0/5 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
Eye disorders Eye disorders - Other, Eye disorders - Lt orbital solitary	0.00% 0/5 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/5 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	16.7% 1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
Infections and infestations Lung infection	20.0% 1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	0.00% 0/5 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.
General disorders Pain	0.00% 0/5 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups.. Data is grouped as specified per protocol.

Other adverse events

Additional Information

Dr. Raffit Hassan

National Cancer Institute

Phone: 240-760-6232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place