Trial Outcomes & Findings for An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO) (NCT NCT00726661)
NCT ID: NCT00726661
Last Updated: 2017-07-11
Results Overview
Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.
Recruitment status
COMPLETED
Target enrollment
1287 participants
Primary outcome timeframe
Approximately 4.5 years
Results posted on
2017-07-11
Participant Flow
This study was conducted from 01 June 2008 to 31 December 2012 in the United States. A total of 1287 participants were enrolled.
Out of 1287 participants, 20 were not eligible for the study and were excluded. Of 1267 participants, 832 were observed in Chemotherapy cohort and 435 were observed in Hormonal Therapy cohort.
Participant milestones
| Measure |
Chemotherapy Cohort
Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Overall Study
STARTED
|
832
|
435
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
814
|
418
|
Reasons for withdrawal
| Measure |
Chemotherapy Cohort
Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
36
|
11
|
|
Overall Study
Withdrawal by Subject
|
17
|
13
|
|
Overall Study
Trial terminated by sponsor
|
214
|
187
|
|
Overall Study
Death
|
475
|
159
|
|
Overall Study
Physician Decision
|
25
|
13
|
|
Overall Study
Other
|
47
|
35
|
Baseline Characteristics
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)
Baseline characteristics by cohort
| Measure |
Chemotherapy Cohort
n=832 Participants
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 Participants
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Total
n=1267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.40 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
63.99 years
STANDARD_DEVIATION 12.57 • n=7 Participants
|
59.66 years
STANDARD_DEVIATION 12.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
826 Participants
n=5 Participants
|
434 Participants
n=7 Participants
|
1260 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 4.5 yearsPopulation: All enrolled participants were considered for this outcome measure.
Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.
Outcome measures
| Measure |
Chemotherapy Cohort
n=832 Participants
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 Participants
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Progression Free Survival
|
8.54 months
Interval 8.02 to 9.2
|
12.88 months
Interval 10.81 to 14.69
|
SECONDARY outcome
Timeframe: Approximately 4.5 yearsPopulation: All enrolled participants were considered for this outcome measure.
Overall survival was defined as the time from enrolment to death of any cause.
Outcome measures
| Measure |
Chemotherapy Cohort
n=832 Participants
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 Participants
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Overall Survival
|
23.92 months
Interval 22.24 to 26.71
|
44.78 months
Interval 39.85 to
Upper limit of confidence interval was non-estimable because of immaturity of follow-up.
|
SECONDARY outcome
Timeframe: Approximately 4.5 yearsPopulation: All enrolled participants were considered for this outcome measure.
The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.
Outcome measures
| Measure |
Chemotherapy Cohort
n=832 Participants
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 Participants
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Number of Participants With Tumor Response
Complete response
|
133 participants
|
34 participants
|
|
Number of Participants With Tumor Response
Partial response
|
259 participants
|
107 participants
|
|
Number of Participants With Tumor Response
Stable disease
|
226 participants
|
180 participants
|
|
Number of Participants With Tumor Response
Progressive disease
|
148 participants
|
86 participants
|
|
Number of Participants With Tumor Response
Clinical deterioration
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Approximately 4.5 yearsPopulation: All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point.
Participants were assessed quarterly for progressive events and treatment status.
Outcome measures
| Measure |
Chemotherapy Cohort
n=435 Participants
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
Third quarter (n = 81)
|
39 participants
|
—
|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
Fourth quarter (n = 92)
|
45 participants
|
—
|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
Fifth quarter (n = 99)
|
45 participants
|
—
|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
First quarter (n = 93)
|
37 participants
|
—
|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
Second quarter (n = 91)
|
40 participants
|
—
|
|
Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation
Sixth quarter (n = 83)
|
44 participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 4.5 yearsPopulation: All enrolled participants were considered for this outcome measure.
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Outcome measures
| Measure |
Chemotherapy Cohort
n=832 Participants
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 Participants
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death
Any AEs
|
46 participants
|
13 participants
|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death
Any SAEs
|
76 participants
|
22 participants
|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death
Any AEs leading to early treatment discontinuation
|
89 participants
|
19 participants
|
|
Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death
AEs leading to hospitalization or death
|
67 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Approximately 4.5 yearsPopulation: All enrolled participants were considered for this outcome measure.
All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.
Outcome measures
| Measure |
Chemotherapy Cohort
n=832 Participants
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 Participants
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy
ATE (any Grade)
|
10 participants
|
5 participants
|
|
Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy
VTE (Grade >= 4)
|
14 participants
|
6 participants
|
|
Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy
LVSD (Grade >= 2)
|
16 participants
|
4 participants
|
|
Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy
PN (Grade >= 3)
|
17 participants
|
3 participants
|
Adverse Events
Chemotherapy Cohort
Serious events: 76 serious events
Other events: 46 other events
Deaths: 0 deaths
Hormonal Therapy Cohort
Serious events: 22 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy Cohort
n=832 participants at risk
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 participants at risk
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Infections and infestations
Infection-left breast
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Line associated bacteremia (vascular chest port infection)
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Pneumonia
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Sepsis
|
0.36%
3/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Septic shock
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Severe thrush
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture right hip
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Intertrochanteric hip fracture
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Investigations
Febrile neutropenia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
4/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypercalcemeia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Pain musculoskeletal joint
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Pathologic fracture of the femur
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
T4 intramedullary mass
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Acute left occipital infarct
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Cord compression
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Hemorrhagic mass in brain
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Neuropathy
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Peripheral neuropathy
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Posterior reversible encephtalopathy syndrome
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Psychiatric disorders
Confusion
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Renal and urinary disorders
Acute renal failure
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Renal and urinary disorders
Polyneuropathy
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary embolism
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pulmonary emboli
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.48%
4/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis (nose hemorrhage)
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Left lung atelectasis
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emboli
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.48%
4/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism Grade 3
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolization
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Bilateral subdural hematoma
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Neutropenic sepsis
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Acute systolic heart failure
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Congestive heart failure
|
0.48%
4/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Coronary artery ischemia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Heart attack
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Left ventricular systolic dysfunction (Grade >=2)
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Left ventricular systolic dysfunction (Grade 3)
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Left ventricular systolic dysfunction (Grade 4)
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Pericardial effusion with impending tamponade
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Recurrent transient ischemic attack
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.46%
2/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Ileus
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Intractable nausea
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Perforated diverticulum
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Perforation colon (Grade 1)
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Persistant vomiting
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Viral gastroenteritis
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Chest pain
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Hospitalization for weakness that ended in death (cause unknown)
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Pain
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Weakness
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Hepatobiliary disorders
Hepatic insufficiency related to metastatic breast cancer
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Immune system disorders
Allergic reaction
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Abdominal abscess
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Abdominal sepsis
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Infection
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Infections and infestations
Infection peritioneal cavity
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Bilateral leg ulcers
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Cellulitis of the left upper extremity
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Left heel ulcer
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Arterial thromboembolic events
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.46%
2/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Elevated blood pressure
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Hemorrhage
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Hypotension
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Moderate size infarct involving a portion of the right middle cerebral artery territory
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Multi-organ failure (shock)
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Severe venous thromboembolic event (Grade > =4)
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Stroke
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Thromboembolic event
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Thrombosis/embolism
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Thrombosis/thrombus/embolism - pulmonary embolism
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
Other adverse events
| Measure |
Chemotherapy Cohort
n=832 participants at risk
Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
Hormonal Therapy Cohort
n=435 participants at risk
Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
|
|---|---|---|
|
Cardiac disorders
Left ventricular systolic dysfunction (Grade >=2)
|
0.60%
5/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.69%
3/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Congestive heart failure
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Cardiac disorders
Decreased ejection fraction
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Anemia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Worsening anemia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Investigations
Intermittent nosebleeds grade 1
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion indicating disease progression
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Hot flashes
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Arterial thromboembolic event
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Vascular disorders
Venous thromboembolic event (Grade > =4)
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Infusional reaction
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Infusion reaction Grade II
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Fatigue
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
General disorders
Weakness
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of the jaw
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Pain-musculoskeletal-joint
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Nail toxicity
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Bilateral hand neuropathy
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Peripheral neuropathy (Grade >=3)
|
1.7%
14/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.69%
3/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Peripheral neuropathy
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Peripheral neuropathy (motor or sensory) (grade >= 3)
|
0.96%
8/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Sensory neuropathy
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Sensory neuropathy grade 2
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Tingling in fingers grade I
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Neuropathy
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Neuropathy of toes and clinical progression
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Dizziness
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Nervous system disorders
Dizzy spells
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Eye disorders
Blurred vision
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Diarrhea
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Mucositis
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Investigations
Weight loss
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Recurrent right pleural effusion
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.12%
1/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.23%
1/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Immune system disorders
Allergic reaction
|
0.36%
3/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.24%
2/832 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
0.00%
0/435 • Approximately 4.5 years
SAEs and other AEs were collected for all enrolled participants.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
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