Trial Outcomes & Findings for A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study (NCT NCT04215146)
NCT ID: NCT04215146
Last Updated: 2025-01-16
Results Overview
Overall response rate at week 16 according to RECIST V1.1
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
at week 16
Results posted on
2025-01-16
Participant Flow
Participant milestones
| Measure |
Paclitaxel
Patients receive paclitaxel alone.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
|
Pelareorep + Paclitaxel
Patients receive pelareorep + paclitaxel.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
|
Pelareorep + Paclitaxel + Avelumab
Patients receive pelareorep + paclitaxel + avelumab.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
Avelumab: Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
Baseline characteristics by cohort
| Measure |
Pelareorep
n=15 Participants
Patients receive paclitaxel alone.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
|
Pelareorep + Paclitaxel
n=16 Participants
Patients receive pelareorep + paclitaxel.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
|
Pelareorep + Paclitaxel + Avelumab
n=17 Participants
Patients receive pelareorep + paclitaxel + avelumab.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
Avelumab: Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.
|
Total
n=48 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
60.5 years
n=5 Participants
|
52.8 years
n=7 Participants
|
55.1 years
n=5 Participants
|
56.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
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
|
|
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
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: at week 16Overall response rate at week 16 according to RECIST V1.1
Outcome measures
| Measure |
Pelareorep
n=15 Participants
Patients receive paclitaxel alone.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
|
Pelareorep + Paclitaxel
n=16 Participants
Patients receive pelareorep + paclitaxel.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
|
Pelareorep + Paclitaxel + Avelumab
n=17 Participants
Patients receive pelareorep + paclitaxel + avelumab.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
Avelumab: Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.
|
|---|---|---|---|
|
Overall Response Rate
|
20 percentage of participants
Interval 7.6 to 39.3
|
31.3 percentage of participants
Interval 16.1 to 50.4
|
14.3 percentage of participants
Interval 3.9 to 33.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first day of study treatment to 30 days after of last day of study treatment; up to 27 monthsPopulation: The Safety Analysis set comprises all patients who received any amount of study treatment. A total of 48 patients were enrolled. In the Paclitaxel Arm, 15 patients were randomized / 12 patients recieved study treatment.
Graded by the NCI CTCAE v. 5.0.
Outcome measures
| Measure |
Pelareorep
n=12 Participants
Patients receive paclitaxel alone.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
|
Pelareorep + Paclitaxel
n=16 Participants
Patients receive pelareorep + paclitaxel.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
|
Pelareorep + Paclitaxel + Avelumab
n=17 Participants
Patients receive pelareorep + paclitaxel + avelumab.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
Avelumab: Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.
|
|---|---|---|---|
|
The Number of Patients With Adverse Events and Serious Adverse Events
|
12 Participants
|
16 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 years of study treatmentAssessed by T cell receptor (CDR3 variable chain) sequencing in all patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 years of study participationOverall response rate according to RECIST V1.1
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 years of study participationOverall Survival assessed at end of study
Outcome measures
Outcome data not reported
Adverse Events
Pelareorep
Serious events: 0 serious events
Other events: 12 other events
Deaths: 1 deaths
Pelareorep + Paclitaxel
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Pelareorep + Paclitaxel + Avelumab
Serious events: 13 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pelareorep
n=12 participants at risk
Patients receive paclitaxel alone.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
|
Pelareorep + Paclitaxel
n=16 participants at risk
Patients receive pelareorep + paclitaxel.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
|
Pelareorep + Paclitaxel + Avelumab
n=17 participants at risk
Patients receive pelareorep + paclitaxel + avelumab.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
Avelumab: Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.
|
|---|---|---|---|
|
General disorders
Malaise
|
0.00%
0/12 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
0.00%
0/17 • 27 months
|
|
General disorders
Pyrexia
|
0.00%
0/12 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • 27 months
|
0.00%
0/16 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • 27 months
|
0.00%
0/16 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/12 • 27 months
|
0.00%
0/16 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • 27 months
|
0.00%
0/16 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • 27 months
|
0.00%
0/16 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
0.00%
0/17 • 27 months
|
|
General disorders
Fatigue
|
0.00%
0/12 • 27 months
|
0.00%
0/16 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • 27 months
|
0.00%
0/16 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
Other adverse events
| Measure |
Pelareorep
n=12 participants at risk
Patients receive paclitaxel alone.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
|
Pelareorep + Paclitaxel
n=16 participants at risk
Patients receive pelareorep + paclitaxel.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
|
Pelareorep + Paclitaxel + Avelumab
n=17 participants at risk
Patients receive pelareorep + paclitaxel + avelumab.
Paclitaxel: Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
Avelumab: Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.
|
|---|---|---|---|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5 • 27 months
|
75.0%
12/16 • Number of events 12 • 27 months
|
47.1%
8/17 • Number of events 8 • 27 months
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • 27 months
|
56.2%
9/16 • Number of events 9 • 27 months
|
76.5%
13/17 • Number of events 13 • 27 months
|
|
General disorders
Chills
|
0.00%
0/12 • 27 months
|
43.8%
7/16 • Number of events 7 • 27 months
|
35.3%
6/17 • Number of events 6 • 27 months
|
|
General disorders
Oedema peripheral
|
16.7%
2/12 • Number of events 2 • 27 months
|
37.5%
6/16 • Number of events 6 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • 27 months
|
25.0%
4/16 • Number of events 4 • 27 months
|
29.4%
5/17 • Number of events 5 • 27 months
|
|
General disorders
Pain
|
0.00%
0/12 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Number of events 1 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
4/12 • Number of events 4 • 27 months
|
31.2%
5/16 • Number of events 5 • 27 months
|
41.2%
7/17 • Number of events 7 • 27 months
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • 27 months
|
43.8%
7/16 • Number of events 7 • 27 months
|
29.4%
5/17 • Number of events 5 • 27 months
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • 27 months
|
37.5%
6/16 • Number of events 6 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • Number of events 2 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
29.4%
5/17 • Number of events 5 • 27 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
0.00%
0/17 • 27 months
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
4/12 • Number of events 4 • 27 months
|
43.8%
7/16 • Number of events 7 • 27 months
|
52.9%
9/17 • Number of events 9 • 27 months
|
|
Investigations
Neutrophil count decreased
|
25.0%
3/12 • Number of events 3 • 27 months
|
31.2%
5/16 • Number of events 5 • 27 months
|
64.7%
11/17 • Number of events 11 • 27 months
|
|
Investigations
White blood cell count decreased
|
25.0%
3/12 • Number of events 3 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
64.7%
11/17 • Number of events 11 • 27 months
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
4/12 • Number of events 4 • 27 months
|
37.5%
6/16 • Number of events 6 • 27 months
|
35.3%
6/17 • Number of events 6 • 27 months
|
|
Investigations
Blood alkaline phosphatase increased
|
41.7%
5/12 • Number of events 5 • 27 months
|
25.0%
4/16 • Number of events 4 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Investigations
Lymphocyte count decreased
|
25.0%
3/12 • Number of events 3 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
23.5%
4/17 • Number of events 4 • 27 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
35.3%
6/17 • Number of events 6 • 27 months
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Number of events 1 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Investigations
Blood creatine increased
|
16.7%
2/12 • Number of events 2 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
0.00%
0/17 • 27 months
|
|
Investigations
Blood creatinine increased
|
25.0%
3/12 • Number of events 3 • 27 months
|
0.00%
0/16 • 27 months
|
0.00%
0/17 • 27 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
4/12 • Number of events 4 • 27 months
|
37.5%
6/16 • Number of events 6 • 27 months
|
29.4%
5/17 • Number of events 5 • 27 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
41.7%
5/12 • Number of events 5 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
23.5%
4/17 • Number of events 4 • 27 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
3/12 • Number of events 3 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
23.5%
4/17 • Number of events 4 • 27 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
3/12 • Number of events 3 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
29.4%
5/17 • Number of events 5 • 27 months
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 1 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Number of events 5 • 27 months
|
43.8%
7/16 • Number of events 7 • 27 months
|
52.9%
9/17 • Number of events 9 • 27 months
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 2 • 27 months
|
50.0%
8/16 • Number of events 8 • 27 months
|
47.1%
8/17 • Number of events 8 • 27 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 2 • 27 months
|
25.0%
4/16 • Number of events 4 • 27 months
|
29.4%
5/17 • Number of events 5 • 27 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 3 • 27 months
|
25.0%
4/16 • Number of events 4 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
3/12 • Number of events 3 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
3/12 • Number of events 3 • 27 months
|
0.00%
0/16 • 27 months
|
0.00%
0/17 • 27 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.3%
7/12 • Number of events 7 • 27 months
|
56.2%
9/16 • Number of events 9 • 27 months
|
47.1%
8/17 • Number of events 8 • 27 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
16.7%
2/12 • Number of events 2 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
0.00%
0/17 • 27 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 1 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Blood and lymphatic system disorders
Anaemia
|
58.3%
7/12 • Number of events 7 • 27 months
|
37.5%
6/16 • Number of events 6 • 27 months
|
58.8%
10/17 • Number of events 10 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • Number of events 2 • 27 months
|
25.0%
4/16 • Number of events 4 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
29.4%
5/17 • Number of events 5 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
0.00%
0/17 • 27 months
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • 27 months
|
0.00%
0/16 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
4/12 • Number of events 4 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • Number of events 2 • 27 months
|
0.00%
0/16 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.3%
1/12 • Number of events 1 • 27 months
|
18.8%
3/16 • Number of events 3 • 27 months
|
52.9%
9/17 • Number of events 9 • 27 months
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
2/12 • Number of events 2 • 27 months
|
43.8%
7/16 • Number of events 7 • 27 months
|
23.5%
4/17 • Number of events 4 • 27 months
|
|
Renal and urinary disorders
Haematuria
|
8.3%
1/12 • Number of events 1 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Vascular disorders
Flushing
|
25.0%
3/12 • Number of events 3 • 27 months
|
0.00%
0/16 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Vascular disorders
Hot flush
|
16.7%
2/12 • Number of events 2 • 27 months
|
0.00%
0/16 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • 27 months
|
12.5%
2/16 • Number of events 2 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 1 • 27 months
|
0.00%
0/16 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • 27 months
|
6.2%
1/16 • Number of events 1 • 27 months
|
17.6%
3/17 • Number of events 3 • 27 months
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • 27 months
|
0.00%
0/16 • 27 months
|
11.8%
2/17 • Number of events 2 • 27 months
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • Number of events 2 • 27 months
|
0.00%
0/16 • 27 months
|
5.9%
1/17 • Number of events 1 • 27 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place