Trial Outcomes & Findings for Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer (NCT NCT02630693)
NCT ID: NCT02630693
Last Updated: 2025-11-25
Results Overview
progression free survival (PFS) is defined as time from randomization to progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
2 years
Results posted on
2025-11-25
Participant Flow
Participant milestones
| Measure |
Palbociclib (100mg)
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
90
|
89
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Palbociclib (100mg)
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Overall Study
No receive treatment
|
0
|
1
|
Baseline Characteristics
Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Palbociclib (100mg)
n=90 Participants
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
n=90 Participants
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=45 Participants
|
60 Participants
n=12929 Participants
|
112 Participants
n=6349 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=45 Participants
|
30 Participants
n=12929 Participants
|
68 Participants
n=6349 Participants
|
|
Age, Continuous
|
61.5 years
n=45 Participants
|
59.5 years
n=12929 Participants
|
60.5 years
n=6349 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=45 Participants
|
90 Participants
n=12929 Participants
|
180 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
16 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=45 Participants
|
75 Participants
n=12929 Participants
|
151 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
8 Participants
n=6349 Participants
|
|
Region of Enrollment
Canada
|
90 participants
n=45 Participants
|
90 participants
n=12929 Participants
|
180 participants
n=6349 Participants
|
|
Menopausal Status
Postmenopausal
|
83 Participants
n=45 Participants
|
80 Participants
n=12929 Participants
|
163 Participants
n=6349 Participants
|
|
Menopausal Status
Premenopausal
|
7 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
17 Participants
n=6349 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Intend to treat population
progression free survival (PFS) is defined as time from randomization to progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Palbociclib (100mg)
n=90 Participants
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
n=90 Participants
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Progression Free Survival Using the RECIST 1.1 Criteria
|
9.33 months
Interval 6.93 to 13.9
|
11.30 months
Interval 8.08 to 13.83
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Only patients received protocol treatment were included in this analysis
Response rate = Number of (Complete response + partial response) / total treated patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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 |
Palbociclib (100mg)
n=90 Participants
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
n=89 Participants
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Number of Participants With Response or No Response
Response
|
10 Participants
|
11 Participants
|
|
Number of Participants With Response or No Response
No response
|
80 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 2 yearsFor patients with complete or partial response, duration of response is defined as days from first recorded response to the first date of recurrent or progression or death.
Outcome measures
| Measure |
Palbociclib (100mg)
n=10 Participants
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
n=11 Participants
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Duration of Response
|
126 days
Interval 88.0 to 251.0
|
169 days
Interval 82.0 to 310.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Intend to treat population
Time from randomization to death of any cause.
Outcome measures
| Measure |
Palbociclib (100mg)
n=90 Participants
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
n=90 Participants
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Overall Survival
|
20.73 months
Interval 19.29 to 23.3
|
21.39 months
Interval 19.65 to 26.68
|
Adverse Events
Palbociclib (100mg)
Serious events: 9 serious events
Other events: 89 other events
Deaths: 29 deaths
Palbociclib (125mg)
Serious events: 12 serious events
Other events: 88 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Palbociclib (100mg)
n=90 participants at risk
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
n=89 participants at risk
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
2/90 • Number of events 2 • 2 year
|
0.00%
0/89 • 2 year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
General disorders
Death NOS
|
1.1%
1/90 • Number of events 1 • 2 year
|
2.2%
2/89 • Number of events 2 • 2 year
|
|
General disorders
Fever
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
General disorders
Other general disorders, administration site conditions
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Hepatobiliary disorders
Other hepatobiliary disorders
|
1.1%
1/90 • Number of events 1 • 2 year
|
0.00%
0/89 • 2 year
|
|
Infections and infestations
Lung infection
|
2.2%
2/90 • Number of events 2 • 2 year
|
0.00%
0/89 • 2 year
|
|
Infections and infestations
Sepsis
|
2.2%
2/90 • Number of events 2 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Investigations
Creatinine increased
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Investigations
Platelet count decreased
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.1%
1/90 • Number of events 1 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
2/90 • Number of events 2 • 2 year
|
0.00%
0/89 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
1.1%
1/90 • Number of events 1 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.1%
1/90 • Number of events 1 • 2 year
|
0.00%
0/89 • 2 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/90 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
Other adverse events
| Measure |
Palbociclib (100mg)
n=90 participants at risk
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 100mg: 100mg PO daily
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
Palbociclib (125mg)
n=89 participants at risk
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Palbociclib 125mg: 125mg PO daily 3 weeks out of 4
Fulvestrant or Tamoxifen or Aromatase Inhibitor: given at the standard doses/schedules
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
3.3%
3/90 • Number of events 3 • 2 year
|
5.6%
5/89 • Number of events 5 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.4%
4/90 • Number of events 4 • 2 year
|
5.6%
5/89 • Number of events 5 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
9/90 • Number of events 9 • 2 year
|
9.0%
8/89 • Number of events 8 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.4%
13/90 • Number of events 13 • 2 year
|
15.7%
14/89 • Number of events 14 • 2 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.6%
32/90 • Number of events 32 • 2 year
|
27.0%
24/89 • Number of events 24 • 2 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.4%
13/90 • Number of events 13 • 2 year
|
10.1%
9/89 • Number of events 9 • 2 year
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
22.2%
20/90 • Number of events 20 • 2 year
|
20.2%
18/89 • Number of events 18 • 2 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/90 • 2 year
|
6.7%
6/89 • Number of events 6 • 2 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.6%
14/90 • Number of events 14 • 2 year
|
11.2%
10/89 • Number of events 10 • 2 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
6/90 • Number of events 6 • 2 year
|
6.7%
6/89 • Number of events 6 • 2 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
18/90 • Number of events 18 • 2 year
|
22.5%
20/89 • Number of events 20 • 2 year
|
|
Vascular disorders
Hot flashes
|
27.8%
25/90 • Number of events 25 • 2 year
|
43.8%
39/89 • Number of events 39 • 2 year
|
|
Vascular disorders
Hypertension
|
25.6%
23/90 • Number of events 23 • 2 year
|
28.1%
25/89 • Number of events 25 • 2 year
|
|
Vascular disorders
Lymphedema
|
5.6%
5/90 • Number of events 5 • 2 year
|
6.7%
6/89 • Number of events 6 • 2 year
|
|
Vascular disorders
Thromboembolic event
|
10.0%
9/90 • Number of events 9 • 2 year
|
4.5%
4/89 • Number of events 4 • 2 year
|
|
General disorders
Fever
|
12.2%
11/90 • Number of events 11 • 2 year
|
10.1%
9/89 • Number of events 9 • 2 year
|
|
General disorders
Flu like symptoms
|
24.4%
22/90 • Number of events 22 • 2 year
|
12.4%
11/89 • Number of events 11 • 2 year
|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/90 • Number of events 1 • 2 year
|
5.6%
5/89 • Number of events 5 • 2 year
|
|
General disorders
Pain
|
25.6%
23/90 • Number of events 23 • 2 year
|
21.3%
19/89 • Number of events 19 • 2 year
|
|
Immune system disorders
Allergic reaction
|
5.6%
5/90 • Number of events 5 • 2 year
|
3.4%
3/89 • Number of events 3 • 2 year
|
|
Psychiatric disorders
Depression
|
8.9%
8/90 • Number of events 8 • 2 year
|
27.0%
24/89 • Number of events 24 • 2 year
|
|
Psychiatric disorders
Insomnia
|
48.9%
44/90 • Number of events 44 • 2 year
|
39.3%
35/89 • Number of events 35 • 2 year
|
|
Infections and infestations
Lung infection
|
8.9%
8/90 • Number of events 8 • 2 year
|
3.4%
3/89 • Number of events 3 • 2 year
|
|
Infections and infestations
Other infections and infestations
|
5.6%
5/90 • Number of events 5 • 2 year
|
6.7%
6/89 • Number of events 6 • 2 year
|
|
Infections and infestations
Sinusitis
|
7.8%
7/90 • Number of events 7 • 2 year
|
4.5%
4/89 • Number of events 4 • 2 year
|
|
Infections and infestations
Skin infection
|
11.1%
10/90 • Number of events 10 • 2 year
|
4.5%
4/89 • Number of events 4 • 2 year
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
18/90 • Number of events 18 • 2 year
|
25.8%
23/89 • Number of events 23 • 2 year
|
|
Infections and infestations
Urinary tract infection
|
14.4%
13/90 • Number of events 13 • 2 year
|
7.9%
7/89 • Number of events 7 • 2 year
|
|
Infections and infestations
Wound infection
|
5.6%
5/90 • Number of events 5 • 2 year
|
0.00%
0/89 • 2 year
|
|
Injury, poisoning and procedural complications
Bruising
|
4.4%
4/90 • Number of events 4 • 2 year
|
9.0%
8/89 • Number of events 8 • 2 year
|
|
Injury, poisoning and procedural complications
Fall
|
7.8%
7/90 • Number of events 7 • 2 year
|
6.7%
6/89 • Number of events 6 • 2 year
|
|
Injury, poisoning and procedural complications
Fracture
|
10.0%
9/90 • Number of events 9 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Investigations
Weight loss
|
6.7%
6/90 • Number of events 6 • 2 year
|
5.6%
5/89 • Number of events 5 • 2 year
|
|
Metabolism and nutrition disorders
Anorexia
|
42.2%
38/90 • Number of events 38 • 2 year
|
28.1%
25/89 • Number of events 25 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.4%
22/90 • Number of events 22 • 2 year
|
37.1%
33/89 • Number of events 33 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
5/90 • Number of events 5 • 2 year
|
6.7%
6/89 • Number of events 6 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
27/90 • Number of events 27 • 2 year
|
46.1%
41/89 • Number of events 41 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
41.1%
37/90 • Number of events 37 • 2 year
|
31.5%
28/89 • Number of events 28 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
13.3%
12/90 • Number of events 12 • 2 year
|
9.0%
8/89 • Number of events 8 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.6%
5/90 • Number of events 5 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.1%
19/90 • Number of events 19 • 2 year
|
23.6%
21/89 • Number of events 21 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
6/90 • Number of events 6 • 2 year
|
7.9%
7/89 • Number of events 7 • 2 year
|
|
Renal and urinary disorders
Urinary frequency
|
1.1%
1/90 • Number of events 1 • 2 year
|
9.0%
8/89 • Number of events 8 • 2 year
|
|
Reproductive system and breast disorders
Breast pain
|
5.6%
5/90 • Number of events 5 • 2 year
|
10.1%
9/89 • Number of events 9 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
13.3%
12/90 • Number of events 12 • 2 year
|
19.1%
17/89 • Number of events 17 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
25/90 • Number of events 25 • 2 year
|
31.5%
28/89 • Number of events 28 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.4%
40/90 • Number of events 40 • 2 year
|
38.2%
34/89 • Number of events 34 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.4%
13/90 • Number of events 13 • 2 year
|
12.4%
11/89 • Number of events 11 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.6%
5/90 • Number of events 5 • 2 year
|
3.4%
3/89 • Number of events 3 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
6/90 • Number of events 6 • 2 year
|
9.0%
8/89 • Number of events 8 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
23.3%
21/90 • Number of events 21 • 2 year
|
18.0%
16/89 • Number of events 16 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
42.2%
38/90 • Number of events 38 • 2 year
|
32.6%
29/89 • Number of events 29 • 2 year
|
|
Nervous system disorders
Dizziness
|
18.9%
17/90 • Number of events 17 • 2 year
|
14.6%
13/89 • Number of events 13 • 2 year
|
|
Nervous system disorders
Dysgeusia
|
20.0%
18/90 • Number of events 18 • 2 year
|
14.6%
13/89 • Number of events 13 • 2 year
|
|
Nervous system disorders
Headache
|
37.8%
34/90 • Number of events 34 • 2 year
|
36.0%
32/89 • Number of events 32 • 2 year
|
|
Nervous system disorders
Memory impairment
|
7.8%
7/90 • Number of events 7 • 2 year
|
3.4%
3/89 • Number of events 3 • 2 year
|
|
Nervous system disorders
Other nervous system disorders
|
6.7%
6/90 • Number of events 6 • 2 year
|
3.4%
3/89 • Number of events 3 • 2 year
|
|
Nervous system disorders
Paresthesia
|
14.4%
13/90 • Number of events 13 • 2 year
|
13.5%
12/89 • Number of events 12 • 2 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.6%
5/90 • Number of events 5 • 2 year
|
2.2%
2/89 • Number of events 2 • 2 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.0%
27/90 • Number of events 27 • 2 year
|
33.7%
30/89 • Number of events 30 • 2 year
|
|
Psychiatric disorders
Anxiety
|
27.8%
25/90 • Number of events 25 • 2 year
|
36.0%
32/89 • Number of events 32 • 2 year
|
|
Psychiatric disorders
Confusion
|
5.6%
5/90 • Number of events 5 • 2 year
|
3.4%
3/89 • Number of events 3 • 2 year
|
|
Gastrointestinal disorders
Nausea
|
52.2%
47/90 • Number of events 47 • 2 year
|
53.9%
48/89 • Number of events 48 • 2 year
|
|
Gastrointestinal disorders
Oral pain
|
4.4%
4/90 • Number of events 4 • 2 year
|
5.6%
5/89 • Number of events 5 • 2 year
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
5.6%
5/90 • Number of events 5 • 2 year
|
4.5%
4/89 • Number of events 4 • 2 year
|
|
Gastrointestinal disorders
Toothache
|
5.6%
5/90 • Number of events 5 • 2 year
|
1.1%
1/89 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Vomiting
|
28.9%
26/90 • Number of events 26 • 2 year
|
25.8%
23/89 • Number of events 23 • 2 year
|
|
General disorders
Chills
|
6.7%
6/90 • Number of events 6 • 2 year
|
10.1%
9/89 • Number of events 9 • 2 year
|
|
General disorders
Edema limbs
|
14.4%
13/90 • Number of events 13 • 2 year
|
21.3%
19/89 • Number of events 19 • 2 year
|
|
General disorders
Fatigue
|
85.6%
77/90 • Number of events 77 • 2 year
|
82.0%
73/89 • Number of events 73 • 2 year
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
2/90 • Number of events 2 • 2 year
|
5.6%
5/89 • Number of events 5 • 2 year
|
|
Endocrine disorders
Hypothyroidism
|
4.4%
4/90 • Number of events 4 • 2 year
|
5.6%
5/89 • Number of events 5 • 2 year
|
|
Eye disorders
Blurred vision
|
11.1%
10/90 • Number of events 10 • 2 year
|
7.9%
7/89 • Number of events 7 • 2 year
|
|
Eye disorders
Dry eye
|
7.8%
7/90 • Number of events 7 • 2 year
|
4.5%
4/89 • Number of events 4 • 2 year
|
|
Eye disorders
Other eye disorders
|
4.4%
4/90 • Number of events 4 • 2 year
|
10.1%
9/89 • Number of events 9 • 2 year
|
|
Eye disorders
Watering eyes
|
11.1%
10/90 • Number of events 10 • 2 year
|
4.5%
4/89 • Number of events 4 • 2 year
|
|
Gastrointestinal disorders
Abdominal pain
|
18.9%
17/90 • Number of events 17 • 2 year
|
24.7%
22/89 • Number of events 22 • 2 year
|
|
Gastrointestinal disorders
Bloating
|
6.7%
6/90 • Number of events 6 • 2 year
|
2.2%
2/89 • Number of events 2 • 2 year
|
|
Gastrointestinal disorders
Constipation
|
46.7%
42/90 • Number of events 42 • 2 year
|
43.8%
39/89 • Number of events 39 • 2 year
|
|
Gastrointestinal disorders
Diarrhea
|
45.6%
41/90 • Number of events 41 • 2 year
|
41.6%
37/89 • Number of events 37 • 2 year
|
|
Gastrointestinal disorders
Dry mouth
|
8.9%
8/90 • Number of events 8 • 2 year
|
11.2%
10/89 • Number of events 10 • 2 year
|
|
Gastrointestinal disorders
Dyspepsia
|
12.2%
11/90 • Number of events 11 • 2 year
|
7.9%
7/89 • Number of events 7 • 2 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
23.3%
21/90 • Number of events 21 • 2 year
|
24.7%
22/89 • Number of events 22 • 2 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
3/90 • Number of events 3 • 2 year
|
6.7%
6/89 • Number of events 6 • 2 year
|
|
Gastrointestinal disorders
Mucositis oral
|
25.6%
23/90 • Number of events 23 • 2 year
|
27.0%
24/89 • Number of events 24 • 2 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place