Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer (NCT NCT00846027)
NCT ID: NCT00846027
Last Updated: 2014-07-23
Results Overview
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Baseline to the end of the study (up to 2 years 10 months)
Results posted on
2014-07-23
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
Received Treatment
|
83
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
90
|
Reasons for withdrawal
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Disease Progression
|
30
|
|
Overall Study
Toxicity
|
12
|
|
Overall Study
Patient Decision
|
7
|
|
Overall Study
Investigator Discretion
|
29
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Subject Not Treated
|
7
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
n=90 Participants
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Age, Continuous
|
52.20 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of the study (up to 2 years 10 months)Population: Intent-to-treat population: All participants who were enrolled in the study.
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
n=90 Participants
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Progression-free Survival
|
11.51 Months
Interval 9.01 to 17.59
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 2 years 10 months)Population: Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
n=76 Participants
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Percentage of Participants With an Objective Response
|
72.37 Percentage of participants
Interval 60.91 to 82.01
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 2 years 10 months)Population: Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
n=55 Participants
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Duration of the Objective Response
|
12.39 Months
Interval 7.63 to 15.16
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 2 years 10 months)Population: Intent-to-treat population: All participants who were enrolled in the study.
Overall survival is defined as the time from the first dose of study medication until death.
Outcome measures
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
n=90 Participants
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Survival
|
27.39 Months
Interval 21.86 to
The upper limit of the confidence interval could not be calculated due to too few events.
|
Adverse Events
Bevacizumab + Paclitaxel + Gemcitabine
Serious events: 21 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
n=82 participants at risk
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Dehydration
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Fever
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Catheter site infection
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Febrile neutropenia
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Hypertension
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Confusion
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Dizziness
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Blood and lymphatic system disorders
Neutrophils count decreased
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
Other adverse events
| Measure |
Bevacizumab + Paclitaxel + Gemcitabine
n=82 participants at risk
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
32.9%
27/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
30.5%
25/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.4%
20/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
15.9%
13/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Anorexia
|
12.2%
10/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Dysgeusia
|
6.1%
5/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Periodontal disease
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Perforation, GI
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Dehydration
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Dental: teeth
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Mucositis
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Pain oral-gums
|
34.1%
28/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain muscle
|
22.0%
18/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Pain abdomen
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain joint
|
14.6%
12/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain back
|
11.0%
9/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Pain head/headache
|
8.5%
7/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Pain extremity limb
|
6.1%
5/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Renal and urinary disorders
Pain bladder
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Pain, other
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain bone
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Chest/thorax
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain other back
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain neck
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Gastrointestinal disorders
Pain uterus
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
34.1%
28/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
24.4%
20/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
20.7%
17/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
9.8%
8/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.5%
7/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin, other
|
6.1%
5/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Hand-foot
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis associated with radiation
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Alteration in scarring
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Fatigue
|
65.9%
54/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Fever
|
18.3%
15/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Hot flashes
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Constitutional symptoms, other
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Diaphoresis
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Neuropathy: sensory
|
75.6%
62/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Mood alteration
|
6.1%
5/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Dizziness
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Confusion
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Nervous system disorders
Neuropathy: cranial optic
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Blood and lymphatic system disorders
Neutrophils low
|
31.7%
26/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Blood and lymphatic system disorders
Haemoglobin decreased
|
18.3%
15/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Blood and lymphatic system disorders
Platelets low
|
7.3%
6/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Blood and lymphatic system disorders
Leukocytes low
|
7.3%
6/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Blood and lymphatic system disorders
Blood/bone marrow , other
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage, pulmonary/upper respiratory nose
|
36.6%
30/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage, gastrointestinal oral cavity
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage, gastrointestinal rectum
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage, genitourinary bladder
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage, pulmonary/upper respiratory lung
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage/bleeding, other
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage, gastrointestinal varices (rectal)
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Haemorrhage, genitourinary uterus
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection bladder (urinary)
|
6.1%
5/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection - other nose
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection with unknown absolute neutrophil count
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection, other
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection - other general catheter-related
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection other conjunctiva
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection pharynx
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Febrile neutropenia
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection - other general oral cavity-gums
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection sexual/reproductive function vaginal
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Infections and infestations
Infection vaginal
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.0%
9/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysarthria
|
9.8%
8/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
4/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/paranasal reactions
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Hypertension
|
15.9%
13/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Bradycardia
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Pulmonary hypertension
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Proteinuria
|
3.7%
3/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Alanine transaminase, serum glutamic pyruvic transaminase
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Aspartate aminotransferase
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Metabolic, other
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Alanine transaminase/aspartate aminotransferase high
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Uric acid, serum-high
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Alanine transaminase
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Investigations
Alkaline phosphatase
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Metabolism and nutrition disorders
Oedema: limb
|
9.8%
8/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Metabolism and nutrition disorders
Lymphatics - other lymphangitis
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Eye disorders
Watery eye
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Eye disorders
Eye disorder
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Eye disorders
Ocular/visual
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Eye disorders
Ophthalmoplegia/diplopia
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Endocrine disorders
Irregular menses
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Reproductive system and breast disorders
Sexual/reproductive, other
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Renal and urinary disorders
Cystitis
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Renal and urinary disorders
Bladder spasms
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Immune system disorders
Allergic reaction
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness- extremity lower
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spine-range of motion
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy - possibly related to cancer treatment
|
2.4%
2/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Endocrine disorders
Hot flashes
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Vascular disorders
Phlebitis
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
1.2%
1/82
Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800 821-8590
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