Trial Outcomes & Findings for Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Colorectal Cancer (NCT NCT01733628)

Last Updated: 2019-12-04

Results Overview

The incidence of hypertension was studied during treatment with bevacizumab combined with chemotherapy. A Cox regression analysis was performed, entering as a dependent variable the PFS and as independent variable the Arterial Hypertension (AHT) (yes/no). AHT is introduced in the model of Cox as a time-dependent variable since its situation can change as length of the study. The date on which the AHT changes (passes from normotensive to hypertensive).

Recruitment status

COMPLETED

Target enrollment

143 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2019-12-04

Participant Flow

From October 2012 to July 2016, 143 patients were included.

Participant milestones

Participant milestones
Measure	Bevacizumab + Chemotherapy Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
Overall Study STARTED	143
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab + Chemotherapy n=143 Participants Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
Age, Continuous	61.18 years n=143 Participants
Sex: Female, Male Female	102 Participants n=143 Participants
Sex: Female, Male Male	41 Participants n=143 Participants
Region of Enrollment Spain	143 participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 0	67 Participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 1	72 Participants n=143 Participants
Eastern Cooperative Oncology Group (ECOG) status Unknown	4 Participants n=143 Participants
Blood Pressure Systolic	129.4 mmHg n=143 Participants
Blood Pressure Diastolic	74.73 mmHg n=143 Participants
Pulse	78.92 bpm n=143 Participants
Women Menopausal Status Postmenopausal women	75 Participants n=102 Participants • Only women were assessed for this measure
Women Menopausal Status Premenopausal women	27 Participants n=102 Participants • Only women were assessed for this measure
Previous arterial hypertension Previous arterial hypertension	43 Participants n=143 Participants
Previous arterial hypertension No Previous arterial hypertension	70 Participants n=143 Participants
Previous arterial hypertension Unknown	30 Participants n=143 Participants
Cancer type Metastatic Colorectal Cancer (MCRC)	65 Participants n=143 Participants
Cancer type Metastatic Breast Cancer (MBC)	78 Participants n=143 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: There were 30 patients who were not included in Population per Protocol because of the following: 6 patients didn't fulfil inclusion and exclusion criteria, 8 patients didn't received Bevacizumab, 16 patients didn't have Holter assessment performed at baseline and/or at any other study visit.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=113 Participants Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) No AHT : 0 to 0.5 years	19 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) No AHT : 0.5 to 1 years	11 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) No AHT : 1 to 1.5 years	6 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) No AHT : 1.5 to 2 years	4 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) No AHT : 2 to 2.5 years	1 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) No AHT: 2.5 to 3 years	1 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) Yes AHT: 0 to 0.5 years	94 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) Yes AHT: 0.5 to 1 years	58 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) Yes AHT: 1 to 1.5 years	25 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) Yes AHT: 1.5 to 2 years	13 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) Yes AHT: 2 to 2.5 years	7 Participants
Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS) Yes AHT: 2.5 to 3 years	5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

The PFS is the time from the patient receiving the first dose of chemotherapy for advanced disease to the date of progression, the administration of a new antineoplastic treatment that does not contain bevacizumab or death. 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

Outcome measures
Measure	Bevacizumab + Chemotherapy n=113 Participants Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
Progression Free Survival (PFS)	10.19 Months Standard Deviation 8.77

SECONDARY outcome

Timeframe: Cycle 1, cycle 2, and cycle 3, up to 9 weeks

The incidence of "white coat" arterial hypertension (AHT) was evaluated comparing each of the measurements in medical attention (in a doctor office) with the measurement that was made at home (without a doctor). White Coat Hypertension is a phenomenon in which people exhibit a blood pressure level above the normal range, in a clinical setting, though they do not exhibit it in other settings.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=113 Participants Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 1 · No AHT	60 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 1 · Yes AHT	6 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 1 · Missing	47 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 2 · No AHT	73 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 2 · Yes AHT	10 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 2 · Missing	30 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 3 · No AHT	65 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 3 · Yes AHT	6 Participants
Number of Participants With "White Coat" AHT While at Home White coat AHT in cycle 3 · Missing	42 Participants

SECONDARY outcome

Timeframe: Baseline, cycle 1, cycle 2, and cycle 3, up to 9 weeks

The incidence of "white coat" arterial hypertension (AHT) was evaluated comparing each of the measurements with the measurement that was made in the hospital. Ambulatory Blood Pressure Monitoring (ABPM) is when the blood pressure is being measured as patient moves around, living her normal daily life. White Coat Hypertension is a phenomenon in which people exhibit a blood pressure level above the normal range, in a clinical setting, though they do not exhibit it in other settings.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=113 Participants Patients who received the addition of Bevacizumab (BV) every 2-3 weeks to Chemotherapy (CT) with either oxaliplatin or irinotecan plus fluoropyrimidines in patients with Metastatic Colorectal Cancer (MCRC), either paclitaxel or capecitabine in patients with Metastatic Breast Cancer (MBC), as first-line therapy.
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in baseline · No AHT	94 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in baseline · Yes AHT	14 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in baseline · Missing	5 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 1 · No AHT	66 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 1 · Yes AHT	5 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 1 · Missing	42 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 2 · No AHT	83 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 2 · Yes AHT	9 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 2 · Missing	21 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 3 · No AHT	70 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 3 · Yes AHT	5 Participants
Number of Participants With "White Coat" AHT With 24 Hours Ambulatory BP Measure White coat AHT in cycle 3 · Missing	38 Participants

Adverse Events

Bevacizumab + Chemotherapy

Serious events: 22 serious events

Other events: 57 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab + Chemotherapy n=135 participants at risk The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143).
Cardiac disorders Acute coronary syndrome	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
General disorders Back pain	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Diarrhea	3.7% 5/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.5% 2/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
General disorders Fever	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Gastroenteritis	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Cardiac disorders ICTUS	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Infections and infestations Skin infection: Cellulitis	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Infections and infestations Lynph Gland Infection	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Infections and infestations Lung infection	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
General disorders Malaise	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Infections and infestations Penile infection	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Infections and infestations Soft tissue infection	1.5% 2/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Surgical and medical procedures Coronary Angiography	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Infections and infestations Urinary tract infection	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Renal and urinary disorders Urinary tract obstruction	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Musculoskeletal and connective tissue disorders Abdominal pain	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Metabolism and nutrition disorders Anorexia	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Metabolism and nutrition disorders Dehydration	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Diverticulitis	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Immune system disorders Neutrophil count decreased	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.

Other adverse events

Other adverse events
Measure	Bevacizumab + Chemotherapy n=135 participants at risk The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143).
Investigations GGT increased	5.9% 8/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Cardiac disorders Hypertension	8.1% 11/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Blood and lymphatic system disorders Neutrophil count decreased	8.9% 12/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Blood and lymphatic system disorders Neutrophil Count Decreased	2.2% 3/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Investigations APTT increased	2.2% 3/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Abdominal pain	2.2% 3/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Investigations Alanine aminotransferase increased	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Nervous system disorders Anorexia	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Investigations Aspartate aminotransferase increased	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Blood and lymphatic system disorders Blood bilirubin increased	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
General disorders Dehydration	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Diarrhea	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
General disorders Fatigue	2.2% 3/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Diverticulitis	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Investigations Hyperkalemia	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Investigations Hyponatremia	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Fistulized perianal abscess	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Metabolism and nutrition disorders LDL Cholesterol increased	2.2% 3/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Blood and lymphatic system disorders Lymphopenia	1.5% 2/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Mucositis oral	1.5% 2/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Gastrointestinal disorders Nausea	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.
Skin and subcutaneous tissue disorders Rash/Desquamation	0.74% 1/135 • All adverse events occurred during the treatment and up to 30 days after the last dose were notified. All Serious Adverse Events (SAEs) that occurred within the first 3 cycles were recorded in the electronic Case Report Form (eCRF). Only those Grade 3-4 adverse events that were related to the treatment that occurred during the first 3 treatment cycles were recorded in the eCRF. The Safety Population (SP) included 135 patients who signed the Informed Consent and received at least 1 dose of Chemotherapy combined with Bevacizumab. The Intent to Treat (ITT) Population included 143 patients who signed the Informed Consent. Serious Adverse Events and/or Other (Not Including Serious) Adverse Events (AEs) have been calculated in the SP (n=135), and All-Cause Mortality have been calculated in the ITT population (n=143) as per protocol.

Additional Information

Scientific Director / Medical Lead / Project Manager

Spanish Breast Cancer Research Group

Phone: +34916592870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60