Trial Outcomes & Findings for A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes (NCT NCT04171700)
NCT ID: NCT04171700
Last Updated: 2023-10-02
Results Overview
Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
From first dose of study drug until disease progression (up to approximately 2 years)
Results posted on
2023-10-02
Participant Flow
A total of 83 participants were enrolled across 19 US sites between January 2020 and March 2022. 63 participants were enrolled in cohort A and 20 in cohort B. Cohort A comprised participants with a deleterious mutation in one of the following genes; BRCA1, BRCA2, PALB2, RAD51C, RAD51D. Cohort B comprised participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, RAD51B.
Participant milestones
| Measure |
Rucaparib Cohort A
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
20
|
|
Overall Study
COMPLETED
|
63
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
Baseline characteristics by cohort
| Measure |
Rucaparib Cohort A
n=63 Participants
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 Participants
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 10.85 • n=5 Participants
|
65.2 Years
STANDARD_DEVIATION 13.38 • n=7 Participants
|
64.8 Years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
20 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).
Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
Outcome measures
| Measure |
Rucaparib Cohort A
n=61 Participants
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 Participants
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Best Overall Response Rate by Investigator
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: No data were collected as the independent radiology review was not performed.
Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).
Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.
Outcome measures
| Measure |
Rucaparib Cohort A
n=9 Participants
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=2 Participants
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Duration of Response
|
4.1 month
Interval 3.1 to
Insufficient number of participants with events.
|
6.8 month
Interval 2.6 to 10.9
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).
Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.
Outcome measures
| Measure |
Rucaparib Cohort A
n=61 Participants
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 Participants
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Disease Control Rate
|
36.1 percentage of participants
Interval 24.2 to 49.4
|
25.0 percentage of participants
Interval 8.7 to 49.1
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.
Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.
Outcome measures
| Measure |
Rucaparib Cohort A
n=63 Participants
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 Participants
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Progression-free Survival
|
3.7 month
Interval 1.9 to 5.4
|
3.6 month
Interval 1.6 to 6.3
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.
Measure of clinical benefit, defined as the duration from study enrollment to death.
Outcome measures
| Measure |
Rucaparib Cohort A
n=63 Participants
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 Participants
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Overall Survival
|
13.3 month
Interval 10.6 to
Insufficient number of participants with events.
|
8.0 month
Interval 4.8 to 16.6
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.
Outcome measures
| Measure |
Rucaparib Cohort A
n=63 Participants
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 Participants
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Number of Participants Experiencing Treatment-emergent Adverse Events
|
63 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)Population: Pharmacokinetics data not collected due to early study termination.
Rucaparib pharmacokinetics
Outcome measures
Outcome data not reported
Adverse Events
Rucaparib Cohort A
Serious events: 13 serious events
Other events: 63 other events
Deaths: 23 deaths
Rucaparib Cohort B
Serious events: 5 serious events
Other events: 19 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Rucaparib Cohort A
n=63 participants at risk
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 participants at risk
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Gastrointestinal disorders
Proctalgia
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
General disorders
Fatigue
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Ascites
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Nervous system disorders
Headache
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
Other adverse events
| Measure |
Rucaparib Cohort A
n=63 participants at risk
Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
|
Rucaparib Cohort B
n=20 participants at risk
Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.7%
20/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
25.0%
5/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Cardiac disorders
Bradycardia
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
20.0%
4/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
12/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.5%
23/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Nausea
|
39.7%
25/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
40.0%
8/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
18/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
25.0%
5/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
General disorders
Chills
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
General disorders
Fatigue
|
49.2%
31/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
50.0%
10/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
General disorders
Oedema peripheral
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
General disorders
Pyrexia
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Infections and infestations
COVID-19
|
7.9%
5/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Infections and infestations
Pneumonia
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Alanine aminotransferase increased
|
15.9%
10/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.9%
5/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Blood bilirubin increased
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Blood cholesterol increased
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Blood creatinine increased
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
International normalized ratio increased
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Lymphocyte count decreased
|
12.7%
8/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Neutrophil count decreased
|
15.9%
10/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Platelet count decreased
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
15.0%
3/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Weight decreased
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
Weight increased
|
1.6%
1/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Investigations
White blood cell count decreased
|
15.9%
10/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
15/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
20.0%
4/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
20.0%
4/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.9%
5/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
15.0%
3/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
15.0%
3/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Nervous system disorders
Dizziness
|
17.5%
11/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Nervous system disorders
Dysguesia
|
12.7%
8/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
25.0%
5/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Nervous system disorders
Headache
|
9.5%
6/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
15.0%
3/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Nervous system disorders
Lethargy
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Nervous system disorders
Tremor
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Psychiatric disorders
Insomnia
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Renal and urinary disorders
Chromaturia
|
3.2%
2/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Renal and urinary disorders
Hematuria
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Renal and urinary disorders
Proteinuria
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
9/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
7/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
5.0%
1/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Vascular disorders
Hypertension
|
6.3%
4/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
0.00%
0/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
|
Vascular disorders
Hypotension
|
4.8%
3/63 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
10.0%
2/20 • Adverse event data was collected from the date of first dose of study drug until 28 days after the last dose of study drug, approximately 2 years.
Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place