Trial Outcomes & Findings for A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Participants With HER 2-Negative Aggressive Metastatic Breast Cancer (NCT NCT02613208)
NCT ID: NCT02613208
Last Updated: 2020-02-17
Results Overview
Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels \<5 (\<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations).
Recruitment status
COMPLETED
Target enrollment
111 participants
Primary outcome timeframe
During follow-up (up to 18 months)
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Participants With Metastatic Breast Cancer
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Participants With Metastatic Breast Cancer
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Change of address
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Death
|
37
|
Baseline Characteristics
A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Participants With HER 2-Negative Aggressive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Participants With Metastatic Breast Cancer
n=111 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race : Caucasian
|
105 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race : Latino
|
4 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race : Black
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race : Arab
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: During follow-up (up to 18 months)Population: Included participants that were evaluable for CTC level after cycle 2.
Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels \<5 (\<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations).
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Clinical Benefit
Sensitive · Benefit = Yes
|
53 Participants
|
|
Percentage of Participants With Clinical Benefit
Sensitive · Benefit = No
|
20 Participants
|
|
Percentage of Participants With Clinical Benefit
Resistant · Benefit = Yes
|
5 Participants
|
|
Percentage of Participants With Clinical Benefit
Resistant · Benefit = No
|
7 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to end of study (up to 18 months)Population: Included participants that were evaluable for CTC level after cycle 2.
Overall response = Complete Response (CR) + Partial Response (PR). Overall response was evaluated for the Sensitive group (CTC \<5) and Resistant group (CTC ≥5).
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
Sensitive · Overall Response = Yes
|
35 Participants
|
|
Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
Sensitive · Overall Response = No
|
38 Participants
|
|
Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
Resistant · Overall Response = Yes
|
2 Participants
|
|
Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
Resistant · Overall Response = No
|
10 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to end of study (up to 18 months)Population: Included participants that were evaluable for CTC level after cycle 2.
PFS was evaluated for the Sensitive group (CTC \<5) and Resistant group (CTC ≥5).
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Progression Free Survival (PFS) as Assessed Using RECIST v1.1
Sensitive
|
17.38 months
Interval 15.15 to 19.06
|
|
Progression Free Survival (PFS) as Assessed Using RECIST v1.1
Resistant
|
5.49 months
Interval 2.97 to 8.0
|
SECONDARY outcome
Timeframe: From Baseline up to end of study (up to 18 months)Population: Included only participants that were evaluable for CTC level after cycle 2.
OS was evaluated for the Sensitive group (CTC \<5) and Resistant group (CTC ≥5).
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Overall Survival
Resistant
|
13.01 months
Interval 5.82 to 20.2
|
|
Overall Survival
Sensitive
|
NA months
Median OS in patients with CTCs \<5 was not achieved
|
SECONDARY outcome
Timeframe: From Baseline up to end of study (up to 18 months)Population: Included only participants that were evaluable for CTC level after cycle 2.
Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0). Any AEs that are not specifically listed in the NCI CTCAE follow the logic - Grade 3) Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4: Life-threatening consequences or urgent intervention indicated.
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
Sensitive · Grade 3-4 toxicity = yes
|
28 Participants
|
|
Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
Sensitive · Grade 3-4 toxicity = no
|
45 Participants
|
|
Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
Resistant · Grade 3-4 toxicity = yes
|
6 Participants
|
|
Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
Resistant · Grade 3-4 toxicity = no
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)Population: Included only participants that were evaluable for CTC level after cycle 2.
Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. The optimal cut-off for clinical benefit was calculated from a Receiver Operating Curve (ROC) based on CTC level and used to define the prognostic factors that could better predict clinical outcomes.
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Optimal Cut-off for Clinical Benefit
|
0.5 cells/7.5 ml
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)Population: Included only participants that were evaluable for CTC level after cycle 2.
Overall response = CR + PR. An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
CTC >0.5 · Overall Response = No
|
27 Participants
|
|
Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
CTC >0.5 · Overall Response = Yes
|
14 Participants
|
|
Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
CTC ≤0.5 · Overall Response = Yes
|
23 Participants
|
|
Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
CTC ≤0.5 · Overall Response = No
|
21 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to end of study (up to 18 months)Population: Included only participants that were evaluable for CTC level after cycle 2.
An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=85 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
PFS as Assessed Using RECIST v1. in Prognostic Groups
CTC <0.5
|
22.60 months
Not estimable due to insufficient number of participants with events.
|
|
PFS as Assessed Using RECIST v1. in Prognostic Groups
CTC ≥0.5
|
8.05 months
Interval 5.35 to 10.75
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])Population: Only included participants that had available data of CTC levels at baseline
CTC and CEA levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=89 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Mean CTC Count Levels
CTC (baseline CTC)
|
91.6 count/7.5 ml (CTC)
Standard Deviation 355.5
|
|
Mean CTC Count Levels
CTC (cycle 2 CTC)
|
3.9 count/7.5 ml (CTC)
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])Population: Only included participants that had available data of CEA levels at baseline
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=89 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Mean Carcinoembryonic Antigen (CEA) Levels
|
46.5 U/ml
Standard Deviation 146.2
|
SECONDARY outcome
Timeframe: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])Population: Only included participants that had available data of CA 15.3 levels at baseline
CTC and CA 15.3 levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=95 Participants
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level
|
277.8 U/ml
Standard Deviation 431.3
|
Adverse Events
Participants With Metastatic Breast Cancer
Serious events: 37 serious events
Other events: 107 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Participants With Metastatic Breast Cancer
n=111 participants at risk
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.6%
4/111 • From Baseline up to end of study (up to 18 months)
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Cardiac disorders
PALPITATIONS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Eye disorders
DIPLOPIA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
ASCITES
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
ENTERITIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.8%
2/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
NAUSEA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
VOMITING
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
DISEASE PROGRESSION
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
FATIGUE
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.8%
2/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
PYREXIA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
VASCULAR DEVICE INFECTION
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Infections and infestations
ABDOMINAL SEPSIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Infections and infestations
UROSEPSIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
1.8%
2/111 • From Baseline up to end of study (up to 18 months)
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
CONFUSIONAL STATE
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
EXTRAOCULAR MUSCLE PARESIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.7%
3/111 • From Baseline up to end of study (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
1.8%
2/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
HYPERTENSION
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
PULMONARY EMBOLISM
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
SUBDURAL HAEMATOMA
|
0.90%
1/111 • From Baseline up to end of study (up to 18 months)
|
Other adverse events
| Measure |
Participants With Metastatic Breast Cancer
n=111 participants at risk
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
20.7%
23/111 • From Baseline up to end of study (up to 18 months)
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
16.2%
18/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.1%
9/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.7%
23/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
DIARRHOEA
|
36.9%
41/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
DYSGEUSIA
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
8.1%
9/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
NAUSEA
|
26.1%
29/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
STOMATITIS
|
9.9%
11/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
TOOTHACHE
|
6.3%
7/111 • From Baseline up to end of study (up to 18 months)
|
|
Gastrointestinal disorders
VOMITING
|
15.3%
17/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
ASTHENIA
|
45.9%
51/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
CHEST PAIN
|
6.3%
7/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
FATIGUE
|
22.5%
25/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
INFUSION RELATED REACTION
|
6.3%
7/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
MUCOSAL INFLAMMATION
|
10.8%
12/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
PAIN
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
General disorders
PYREXIA
|
16.2%
18/111 • From Baseline up to end of study (up to 18 months)
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
8.1%
9/111 • From Baseline up to end of study (up to 18 months)
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
8.1%
9/111 • From Baseline up to end of study (up to 18 months)
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
8.1%
9/111 • From Baseline up to end of study (up to 18 months)
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
13.5%
15/111 • From Baseline up to end of study (up to 18 months)
|
|
Investigations
PLATELET COUNT DECREASED
|
9.9%
11/111 • From Baseline up to end of study (up to 18 months)
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.7%
13/111 • From Baseline up to end of study (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.2%
18/111 • From Baseline up to end of study (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
13.5%
15/111 • From Baseline up to end of study (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
6.3%
7/111 • From Baseline up to end of study (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
10.8%
12/111 • From Baseline up to end of study (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.6%
14/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
DIZZINESS
|
6.3%
7/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
HEADACHE
|
16.2%
18/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
19.8%
22/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
NEUROTOXICITY
|
16.2%
18/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
PARAESTHESIA
|
13.5%
15/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
7.2%
8/111 • From Baseline up to end of study (up to 18 months)
|
|
Nervous system disorders
POLYNEUROPATHY
|
13.5%
15/111 • From Baseline up to end of study (up to 18 months)
|
|
Psychiatric disorders
ANXIETY
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
Psychiatric disorders
INSOMNIA
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
Renal and urinary disorders
PROTEINURIA
|
8.1%
9/111 • From Baseline up to end of study (up to 18 months)
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.6%
14/111 • From Baseline up to end of study (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.2%
18/111 • From Baseline up to end of study (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
NASOPHARYNGITIS
|
11.7%
13/111 • From Baseline up to end of study (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFECTION
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
31.5%
35/111 • From Baseline up to end of study (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
7.2%
8/111 • From Baseline up to end of study (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
NAIL TOXICITY
|
13.5%
15/111 • From Baseline up to end of study (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
10.8%
12/111 • From Baseline up to end of study (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
22.5%
25/111 • From Baseline up to end of study (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
RASH
|
10.8%
12/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
EPISTAXIS
|
43.2%
48/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
HYPERTENSION
|
43.2%
48/111 • From Baseline up to end of study (up to 18 months)
|
|
Vascular disorders
RECTAL HAEMORRHAGE
|
5.4%
6/111 • From Baseline up to end of study (up to 18 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER