Trial Outcomes & Findings for A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer (NCT NCT00121836)
NCT ID: NCT00121836
Last Updated: 2011-04-27
Results Overview
Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
approximately 505 days (Median Time to Death)
Results posted on
2011-04-27
Participant Flow
Participant milestones
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
|---|---|
|
Overall Study
STARTED
|
109
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
n=109 Participants
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
|---|---|
|
Age Continuous
|
56.7 Years
STANDARD_DEVIATION 12.03 • n=93 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: approximately 505 days (Median Time to Death)Population: 109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.
Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death
Outcome measures
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
n=109 Participants
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
First Study Treatment Phase Only
Capecitabine+Bevacizumab:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
|
|---|---|---|
|
Overall Survival
|
505 Days
Interval 420.0 to 672.0
|
—
|
SECONDARY outcome
Timeframe: Throughout studyPopulation: 109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.
The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution.
Outcome measures
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
n=109 Participants
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
First Study Treatment Phase Only
n=55 Participants
Capecitabine+Bevacizumab:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
|
|---|---|---|
|
Number of Subjects With Adverse Events
At least 1 adverse event (AE)
|
108 Participants
|
54 Participants
|
|
Number of Subjects With Adverse Events
At least 1 treatment-related AE
|
104 Participants
|
51 Participants
|
|
Number of Subjects With Adverse Events
At least 1 Grade 3 or 4 AE
|
82 Participants
|
41 Participants
|
|
Number of Subjects With Adverse Events
At least 1 serious adverse event (SAE)
|
39 Participants
|
22 Participants
|
|
Number of Subjects With Adverse Events
At least 1 AE causing withdrawal
|
37 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Throughout studyPopulation: 109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.
The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.
Outcome measures
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
n=109 Participants
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
First Study Treatment Phase Only
n=55 Participants
Capecitabine+Bevacizumab:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
|
|---|---|---|
|
Premature Withdrawal From Study Due to Adverse Events
General disorders, administration site conditions
|
4 Participants
|
7 Participants
|
|
Premature Withdrawal From Study Due to Adverse Events
All system organ classes
|
25 Participants
|
37 Participants
|
|
Premature Withdrawal From Study Due to Adverse Events
Musculoskeletal and connective tissue disorders
|
2 Participants
|
6 Participants
|
|
Premature Withdrawal From Study Due to Adverse Events
Respiratory, thoracic and mediastinal disorders
|
2 Participants
|
5 Participants
|
|
Premature Withdrawal From Study Due to Adverse Events
Renal and urinary disorders
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: until progressive disease or for up to 3 yearsPopulation: 109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.
The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in \>= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.
Outcome measures
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
n=109 Participants
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
First Study Treatment Phase Only
Capecitabine+Bevacizumab:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils (10^9/L) (n=92); Abnormality: Low
|
25 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Prothrombin time (ratio) (n=36); Abnormality: High
|
3 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Aspartate transaminase(U/L)(n=104)Abnormality:High
|
19 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Alanine transaminase(U/L)(n=104);Abnormality: High
|
10 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Alkaline phosphatase(U/L)(n=104);Abnormality: High
|
11 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Direct bilirubin (umol/L) (n=78);Abnormality: High
|
4 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Hematocrit (fraction) (n=104); Abnormality: Low
|
16 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Hemoglobin (g/L) (n=104); Abnormality: Low
|
18 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Platelets (10^9/L) (n=104); Abnormality: Low
|
9 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Red blood cells (10¹²/L) (n=104); Abnormality: Low
|
15 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
White blood cells (10^9/L)(n=104); Abnormality:Low
|
23 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils (10^9/L) (n=92); Abnormality: High
|
14 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Albumin (g/L) (n=104); Abnormality: Low
|
13 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Total protein (g/L) (n=104); Abnormality: Low
|
8 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Chloride (mmol/L) (n=104); Abnormality: Low
|
5 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Calcium (mmol/L) (n=104); Abnormality: Low
|
10 Participants
|
—
|
|
Number of Participants With Marked Laboratory Abnormalities
Uric acid (umol/L) (n=94); Abnormality: High
|
5 Participants
|
—
|
Adverse Events
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
Serious events: 39 serious events
Other events: 103 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
n=109 participants at risk
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.92%
1/109
|
|
Cardiac disorders
Left Ventricular Failure
|
0.92%
1/109
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Meninges
|
0.92%
1/109
|
|
Renal and urinary disorders
Renal Failure
|
0.92%
1/109
|
|
General disorders
Pain
|
5.5%
6/109
|
|
General disorders
Chest Pain
|
2.8%
3/109
|
|
General disorders
Mucosal Inflammation
|
1.8%
2/109
|
|
General disorders
Fatigue
|
0.92%
1/109
|
|
General disorders
Influenza Like Illness
|
0.92%
1/109
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/109
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
3/109
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.92%
1/109
|
|
Gastrointestinal disorders
Caecitis
|
0.92%
1/109
|
|
Gastrointestinal disorders
Diarrhoea
|
0.92%
1/109
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.92%
1/109
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.92%
1/109
|
|
Gastrointestinal disorders
Pancreatitis
|
0.92%
1/109
|
|
Infections and infestations
Bacterial Sepsis
|
0.92%
1/109
|
|
Infections and infestations
Cellulitis
|
0.92%
1/109
|
|
Infections and infestations
Infection
|
0.92%
1/109
|
|
Infections and infestations
Perirectal Abscess
|
0.92%
1/109
|
|
Infections and infestations
Pneumonia
|
0.92%
1/109
|
|
Infections and infestations
Sepsis
|
0.92%
1/109
|
|
Infections and infestations
Urinary Tract Infection
|
0.92%
1/109
|
|
Infections and infestations
Urosepsis
|
0.92%
1/109
|
|
Metabolism and nutrition disorders
Dehydration
|
4.6%
5/109
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.92%
1/109
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.92%
1/109
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.8%
3/109
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.92%
1/109
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.92%
1/109
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.92%
1/109
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.8%
2/109
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.92%
1/109
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.92%
1/109
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.92%
1/109
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.92%
1/109
|
|
Injury, poisoning and procedural complications
Fall
|
0.92%
1/109
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.92%
1/109
|
|
Injury, poisoning and procedural complications
Scapula Fracture
|
0.92%
1/109
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.92%
1/109
|
|
Nervous system disorders
Headache
|
0.92%
1/109
|
|
Nervous system disorders
Lethargy
|
0.92%
1/109
|
|
Investigations
Blood Sodium Decreased
|
0.92%
1/109
|
|
Investigations
Haemoglobin Decreased
|
0.92%
1/109
|
|
Investigations
Urine Output Decreased
|
0.92%
1/109
|
|
Vascular disorders
Haemorrhage
|
0.92%
1/109
|
|
Vascular disorders
Phlebitis
|
0.92%
1/109
|
Other adverse events
| Measure |
Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev
n=109 participants at risk
First Study Treatment Phase:
Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.
Second Study Treatment Phase:
Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.
Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.
Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
60.6%
66/109
|
|
Gastrointestinal disorders
Nausea
|
60.6%
66/109
|
|
Gastrointestinal disorders
Constipation
|
37.6%
41/109
|
|
Gastrointestinal disorders
Vomiting
|
33.0%
36/109
|
|
Gastrointestinal disorders
Dyspepsia
|
22.9%
25/109
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
15/109
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.0%
12/109
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.3%
8/109
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.4%
7/109
|
|
Gastrointestinal disorders
Oral Pain
|
5.5%
6/109
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
65.1%
71/109
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
29.4%
32/109
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.3%
21/109
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
11.9%
13/109
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.0%
12/109
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.2%
10/109
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
9/109
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
8.3%
9/109
|
|
General disorders
Fatigue
|
62.4%
68/109
|
|
General disorders
Mucosal Inflammation
|
27.5%
30/109
|
|
General disorders
Pyrexia
|
19.3%
21/109
|
|
General disorders
Pain
|
17.4%
19/109
|
|
General disorders
Asthenia
|
11.9%
13/109
|
|
General disorders
Oedema Peripheral
|
11.9%
13/109
|
|
General disorders
Chills
|
5.5%
6/109
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.6%
29/109
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
25.7%
28/109
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
19.3%
21/109
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
15.6%
17/109
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
8.3%
9/109
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.3%
8/109
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.5%
6/109
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
6/109
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.4%
32/109
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.6%
29/109
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.8%
27/109
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
12.8%
14/109
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
9.2%
10/109
|
|
Nervous system disorders
Headache
|
29.4%
32/109
|
|
Nervous system disorders
Dysgeusia
|
24.8%
27/109
|
|
Nervous system disorders
Neuropathy Peripheral
|
18.3%
20/109
|
|
Nervous system disorders
Dizziness
|
12.8%
14/109
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
5.5%
6/109
|
|
Metabolism and nutrition disorders
Anorexia
|
32.1%
35/109
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
8/109
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.5%
6/109
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
6/109
|
|
Psychiatric disorders
Insomnia
|
20.2%
22/109
|
|
Psychiatric disorders
Depression
|
19.3%
21/109
|
|
Psychiatric disorders
Anxiety
|
11.0%
12/109
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.0%
24/109
|
|
Blood and lymphatic system disorders
Anaemia
|
19.3%
21/109
|
|
Infections and infestations
Sinusitis
|
13.8%
15/109
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.9%
13/109
|
|
Infections and infestations
Urinary Tract Infection
|
11.0%
12/109
|
|
Vascular disorders
Hypertension
|
26.6%
29/109
|
|
Vascular disorders
Hot Flush
|
5.5%
6/109
|
|
Investigations
Weight Decreased
|
11.0%
12/109
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.3%
8/109
|
|
Investigations
Alanine Aminotransferase Increased
|
6.4%
7/109
|
|
Investigations
Neutrophil Count Decreased
|
6.4%
7/109
|
|
Renal and urinary disorders
Proteinuria
|
12.8%
14/109
|
|
Eye disorders
Lacrimation Increased
|
6.4%
7/109
|
Additional Information
Medical Communications
Hoffmann-LaRoche
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