Trial Outcomes & Findings for Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer (NCT NCT02734290)
NCT ID: NCT02734290
Last Updated: 2025-03-10
Results Overview
The count of participants who experienced serious adverse events and grade III/IV treatment-associated adverse events requiring discontinuation of pembrolizumab.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-03-10
Participant Flow
Participant milestones
| Measure |
Arm A (Paclitaxel)
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Paclitaxel)
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Paclitaxel)
n=15 Participants
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
n=14 Participants
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Mean (SD)
|
56 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
63 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
59 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
ECOG Score
Grade 0
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
ECOG Score
Grade 1
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe count of participants who experienced serious adverse events and grade III/IV treatment-associated adverse events requiring discontinuation of pembrolizumab.
Outcome measures
| Measure |
Arm A (Paclitaxel)
n=15 Participants
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
n=14 Participants
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
|---|---|---|
|
Treatment-Associated Adverse Events Requiring Discontinuation
Discontinued Patients
|
2 Participants
|
0 Participants
|
|
Treatment-Associated Adverse Events Requiring Discontinuation
Continued Treatment
|
13 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe number of patients who complete 6 weeks of chemotherapy without requiring a dose delay of more than 21 days.
Outcome measures
| Measure |
Arm A (Paclitaxel)
n=15 Participants
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
n=14 Participants
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
|---|---|---|
|
Number of Patients Who Complete Chemotherapy Without a Dose Delay of More Than 21 Days.
Patients Completed Chemotherapy
|
15 Participants
|
12 Participants
|
|
Number of Patients Who Complete Chemotherapy Without a Dose Delay of More Than 21 Days.
Patients Requiring Dose Delay of More Than 21 Days
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Two patients in Arm A discontinued from study at the 6 week mark and are not evaluable.
Patients will have a computerized tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) scan at 12 weeks to measure the size of target lesions. The percentage of patients whose tumors respond to treatment at 12 weeks will be compared to historical controls. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Outcome measures
| Measure |
Arm A (Paclitaxel)
n=13 Participants
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
n=14 Participants
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
|---|---|---|
|
Overall Response Rate
|
31 percentage of participants
Interval 10.0 to 61.0
|
43 percentage of participants
Interval 18.0 to 71.0
|
Adverse Events
Arm A (Paclitaxel)
Serious events: 5 serious events
Other events: 15 other events
Deaths: 1 deaths
Arm B (Capecitabine)
Serious events: 4 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A (Paclitaxel)
n=15 participants at risk
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
n=14 participants at risk
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Bloating
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Cancer Related Pain
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Cardiac disorders
Chest Pain
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Cardiac disorders
Cardiac Arrest Resulting in Death
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Injury, poisoning and procedural complications
Gram positive bacteremia
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Renal and urinary disorders
Liver failure
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Injury, poisoning and procedural complications
Right hip fracture (femoral neck)
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Cardiac disorders
Syncope
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Vasogenic edema (brain met)
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Worsening cancer pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
Other adverse events
| Measure |
Arm A (Paclitaxel)
n=15 participants at risk
pembrolizumab + weekly paclitaxel
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Paclitaxel: Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
|
Arm B (Capecitabine)
n=14 participants at risk
pembrolizumab + capecitabine
Pembrolizumab: Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
Capecitabine: Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Cramping
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
3/15 • Number of events 3 • ~21 weeks
|
21.4%
3/14 • Number of events 6 • ~21 weeks
|
|
Investigations
Absolute neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Investigations
Activated PTT prolonged
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Nervous system disorders
Acute encephalopathy
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Adhesive Capsulitis
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
5/15 • Number of events 5 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Psychiatric disorders
Amnesia
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
46.7%
7/15 • Number of events 9 • ~21 weeks
|
42.9%
6/14 • Number of events 15 • ~21 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
4/15 • Number of events 5 • ~21 weeks
|
50.0%
7/14 • Number of events 9 • ~21 weeks
|
|
Psychiatric disorders
Anxiety
|
13.3%
2/15 • Number of events 3 • ~21 weeks
|
21.4%
3/14 • Number of events 3 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
General disorders
Edema, limbs
|
33.3%
5/15 • Number of events 6 • ~21 weeks
|
50.0%
7/14 • Number of events 9 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusion
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral tonsillar enlargement with erythema
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Breast Pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
General disorders
Breast tenderness
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Cardiac disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
General disorders
Common cold
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Psychiatric disorders
Confusion
|
0.00%
0/15 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Constipation
|
26.7%
4/15 • Number of events 5 • ~21 weeks
|
35.7%
5/14 • Number of events 5 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
21.4%
3/14 • Number of events 5 • ~21 weeks
|
|
Investigations
Creatinine Increased
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 2 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Cuticle pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
21.4%
3/14 • Number of events 3 • ~21 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
46.7%
7/15 • Number of events 8 • ~21 weeks
|
64.3%
9/14 • Number of events 21 • ~21 weeks
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
21.4%
3/14 • Number of events 3 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Dry desquamation (hand)
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/15 • ~21 weeks
|
21.4%
3/14 • Number of events 3 • ~21 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/15 • ~21 weeks
|
28.6%
4/14 • Number of events 4 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dry nose
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Dry scalp
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
35.7%
5/14 • Number of events 5 • ~21 weeks
|
|
Injury, poisoning and procedural complications
DVT
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Nervous system disorders
Dysgeusia
|
20.0%
3/15 • Number of events 3 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
4/15 • Number of events 5 • ~21 weeks
|
50.0%
7/14 • Number of events 8 • ~21 weeks
|
|
Investigations
Ejection fraction decrease
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Investigations
Elevated AST
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Investigations
Elevated GGT
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Investigations
Elevated PTT
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Emesis
|
6.7%
1/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Erythema
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
General disorders
Facial edema
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
General disorders
Fatigue
|
53.3%
8/15 • Number of events 9 • ~21 weeks
|
64.3%
9/14 • Number of events 13 • ~21 weeks
|
|
General disorders
Fever
|
26.7%
4/15 • Number of events 5 • ~21 weeks
|
28.6%
4/14 • Number of events 9 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Flu like symptoms
|
13.3%
2/15 • Number of events 3 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Psychiatric disorders
Fogginess
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/15 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Hand pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Hand/Foot Syndrome
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
71.4%
10/14 • Number of events 21 • ~21 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • ~21 weeks
|
50.0%
7/14 • Number of events 9 • ~21 weeks
|
|
Ear and labyrinth disorders
Hearing loss left ear
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/15 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Renal and urinary disorders
Hematuria
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Vascular disorders
Hot flashes
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/15 • ~21 weeks
|
14.3%
2/14 • Number of events 3 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 2 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/15 • ~21 weeks
|
14.3%
2/14 • Number of events 10 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
5/15 • Number of events 6 • ~21 weeks
|
35.7%
5/14 • Number of events 5 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
3/15 • Number of events 4 • ~21 weeks
|
21.4%
3/14 • Number of events 4 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
3/15 • Number of events 6 • ~21 weeks
|
57.1%
8/14 • Number of events 9 • ~21 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
14.3%
2/14 • Number of events 6 • ~21 weeks
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/15 • ~21 weeks
|
21.4%
3/14 • Number of events 3 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Number of events 4 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Increased Pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Injury, poisoning and procedural complications
Knee injury
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Leg cramp
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Loss of hand function
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Loss of voice
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Vascular disorders
Lymphedema
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 2 • ~21 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/15 • ~21 weeks
|
28.6%
4/14 • Number of events 12 • ~21 weeks
|
|
General disorders
Malaise
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Nervous system disorders
Memory loss
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Mouth numbness
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Mouth sores
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
14.3%
2/14 • Number of events 3 • ~21 weeks
|
|
Gastrointestinal disorders
Mouth tenderness
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
13.3%
2/15 • Number of events 3 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Nail pain
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Gastrointestinal disorders
Nausea
|
60.0%
9/15 • Number of events 12 • ~21 weeks
|
57.1%
8/14 • Number of events 11 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Neck blisters
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Nervous system disorders
Neuropathy
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 4 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Gastrointestinal disorders
Oral mucositis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Pain, general
|
33.3%
5/15 • Number of events 7 • ~21 weeks
|
35.7%
5/14 • Number of events 7 • ~21 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
1/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
46.7%
7/15 • Number of events 9 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
2/15 • Number of events 2 • ~21 weeks
|
21.4%
3/14 • Number of events 5 • ~21 weeks
|
|
Ear and labyrinth disorders
Plugged Ears, Intermittent
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • ~21 weeks
|
21.4%
3/14 • Number of events 3 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Skin and subcutaneous tissue disorders
Rash (any location)
|
60.0%
9/15 • Number of events 12 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Gastrointestinal disorders
Retching, Intermittent
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Musculoskeletal and connective tissue disorders
Right breast musculoskeletal episode
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
General disorders
Rigors
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Gastrointestinal disorders
Satiety
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Scratchy Throat
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
21.4%
3/14 • Number of events 4 • ~21 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Infections and infestations
Skin infection, left breast
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Eye disorders
Stye (eye infection)
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Blood and lymphatic system disorders
Swollen neck lymph nodes
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.7%
1/15 • Number of events 2 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Injury, poisoning and procedural complications
Temple laceration
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 2 • ~21 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Investigations
Transaminitis
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 2 • ~21 weeks
|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15 • Number of events 3 • ~21 weeks
|
14.3%
2/14 • Number of events 2 • ~21 weeks
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Reproductive system and breast disorders
Vaginal itch, Intermittent
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Eye disorders
Vision changes/disturbance
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
7.1%
1/14 • Number of events 2 • ~21 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 4 • ~21 weeks
|
28.6%
4/14 • Number of events 6 • ~21 weeks
|
|
Investigations
Weight loss
|
0.00%
0/15 • ~21 weeks
|
7.1%
1/14 • Number of events 1 • ~21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/15 • ~21 weeks
|
28.6%
4/14 • Number of events 4 • ~21 weeks
|
|
Investigations
WBC decreased
|
6.7%
1/15 • Number of events 1 • ~21 weeks
|
0.00%
0/14 • ~21 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place