Trial Outcomes & Findings for Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma (NCT NCT00780494)
NCT ID: NCT00780494
Last Updated: 2025-01-14
Results Overview
Tumor progression was assessed according to the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), presented below. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Objective Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria. Progression-Free Survival is assessed as the number of evaluable participants who were alive without disease progression at 1 year. Participants without out assessment at 12 months will not be included.
COMPLETED
PHASE2
35 participants
12 months
2025-01-14
Participant Flow
Indicated participant number is accurate for the number of subjects who started study treatment and completed treatment.
Participant milestones
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma
Baseline characteristics by cohort
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
n=35 Participants
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Those participants who did not receive follow-up at 12 months were considered lost-to-follow-up and not evaluable for progression, and were censored from the analysis.
Tumor progression was assessed according to the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), presented below. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Objective Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria. Progression-Free Survival is assessed as the number of evaluable participants who were alive without disease progression at 1 year. Participants without out assessment at 12 months will not be included.
Outcome measures
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
n=28 Participants
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Progression-Free Survival (PFS)
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants were included in this analysis.
Toxicity was assessed as the number of adverse events ≥ Grade 3 and also possibly, probably, or definitely related to bevacizumab. The outcome is reported as the total number of applicable events, and as the number of events that were a hematologic toxicity; a non-hematologic toxicity; which are numbers without dispersion.
Outcome measures
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
n=35 Participants
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Adverse Events ≥ Grade 3 and Related to Bevacizumab
Total Non-hematologic Toxicities
|
15 Adverse events
|
|
Adverse Events ≥ Grade 3 and Related to Bevacizumab
Total Toxicity Events
|
18 Adverse events
|
|
Adverse Events ≥ Grade 3 and Related to Bevacizumab
Total Hematologic Toxicities
|
3 Adverse events
|
SECONDARY outcome
Timeframe: 7.5 yearsPopulation: Data were available for all participants. Participants remaining alive were censored at last date assessed.
Overall survival (OS) will be assessed from time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis. The outcome is presented as the median survival in days with standard deviation.
Outcome measures
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
n=35 Participants
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Overall Survival (OS)
|
458 Days
Standard Deviation 738
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for clinical response was not available for all participants. Response data are only reported for participants for whom response is known.
Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions, and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays/radiologic scan. Response was determined based on the criteria below. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Objective Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is provided as the number of participants who achieved each of the defined responses, with objective (overall) response defined as the sum of CR and PR. The outcome is reported as values without dispersion.
Outcome measures
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
n=29 Participants
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Objective (Overall) Therapeutic Response
Partial Response
|
18 Participants
|
|
Objective (Overall) Therapeutic Response
Complete Response (CR)
|
0 Participants
|
|
Objective (Overall) Therapeutic Response
Objective Response (OR) = CR + PR
|
18 Participants
|
|
Objective (Overall) Therapeutic Response
Stable Disease
|
6 Participants
|
|
Objective (Overall) Therapeutic Response
Progressive Disease
|
5 Participants
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Based on the objective results, it was determined that the any results from tumor biomarker analyses would be of little value, and the measurement for tumor biomarkers in the collected samples were not conducted. Accordingly, there is no data to be analyzed.
The detected blood levels for tumor biomarkers CEA and CA 19.9 were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 weeksPopulation: Studies published during the conduct of this study demonstrated that this assessment was not useful, and the samples were not collected. Accordingly, there is no data to be analyzed.
The detected blood levels for tumor biomarker vascular endothelial growth factor (VEGF) were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab+ Carboplatin +Capecitabine
Serious adverse events
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
n=35 participants at risk
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
8.6%
3/35 • Number of events 3 • 7.5 years
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
8.6%
3/35 • Number of events 3 • 7.5 years
|
|
Gastrointestinal disorders
Obstruction gastric
|
8.6%
3/35 • Number of events 3 • 7.5 years
|
|
General disorders
Death NOS
|
11.4%
4/35 • Number of events 4 • 7.5 years
|
|
General disorders
Multi-organ failure
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Number of events 2 • 7.5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Vascular disorders
Other, pulmonary embolism
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Hepatobiliary disorders
Hepatic failure
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
General disorders
Chills
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Investigations
Platelet count decreased
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Psychiatric disorders
Confusion
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Plural effusion
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Nervous system disorders
Encephalopathy
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Cardiac disorders
Cardiac arrest
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, disease progression
|
77.1%
27/35 • Number of events 27 • 7.5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
Other adverse events
| Measure |
Bevacizumab+ Carboplatin +Capecitabine
n=35 participants at risk
Participants receive bevacizumab 15 mg/kg intravenously followed by carboplatin AUC 6 intravenously on Day 1 of a 21-day cycle, concurrently with capecitabine 850 mg/m2 twice-daily by mouth on Cycle Days 1-to-14, followed by a 1-week break.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Blood and lymphatic system disorders
Anemia
|
74.3%
26/35 • Number of events 42 • 7.5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
65.7%
23/35 • Number of events 32 • 7.5 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
65.7%
23/35 • Number of events 36 • 7.5 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
85.7%
30/35 • Number of events 45 • 7.5 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
31.4%
11/35 • Number of events 14 • 7.5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Vascular disorders
Hypertension
|
20.0%
7/35 • Number of events 9 • 7.5 years
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Investigations
INR increased
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
General disorders
Fatigue
|
82.9%
29/35 • Number of events 46 • 7.5 years
|
|
General disorders
Chills
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
General disorders
Fever
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Investigations
Weight loss
|
14.3%
5/35 • Number of events 5 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Sweating (hyperhidrosis, diaphoresis)
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
42.9%
15/35 • Number of events 22 • 7.5 years
|
|
Infections and infestations
Rash
|
48.6%
17/35 • Number of events 29 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
4/35 • Number of events 4 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Infections and infestations -Other, specify desquamation
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
15/35 • Number of events 17 • 7.5 years
|
|
Gastrointestinal disorders
Nausea
|
71.4%
25/35 • Number of events 31 • 7.5 years
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
15/35 • Number of events 16 • 7.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
51.4%
18/35 • Number of events 22 • 7.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
17.1%
6/35 • Number of events 7 • 7.5 years
|
|
Gastrointestinal disorders
Mucositis
|
31.4%
11/35 • Number of events 11 • 7.5 years
|
|
Gastrointestinal disorders
Constipation
|
31.4%
11/35 • Number of events 11 • 7.5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders -Other, specify Enteritis
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
5/35 • Number of events 5 • 7.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
3/35 • Number of events 3 • 7.5 years
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.9%
1/35 • Number of events 2 • 7.5 years
|
|
Nervous system disorders
Dysgeusia
|
17.1%
6/35 • Number of events 6 • 7.5 years
|
|
Gastrointestinal disorders
Bloating
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Gastrointestinal disorders
Colitis
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
54.3%
19/35 • Number of events 19 • 7.5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
20.0%
7/35 • Number of events 7 • 7.5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify Hemorrhage Urinary
|
17.1%
6/35 • Number of events 6 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Infections and infestations
Soft tissue infection
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Infections and infestations
Periodontal disease
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
General disorders
Edema limbs
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
5/35 • Number of events 7 • 7.5 years
|
|
Renal and urinary disorders
Proteinuria
|
28.6%
10/35 • Number of events 15 • 7.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
15/35 • Number of events 16 • 7.5 years
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
28.6%
10/35 • Number of events 13 • 7.5 years
|
|
Investigations
Alkaline phosphatase
|
28.6%
10/35 • Number of events 12 • 7.5 years
|
|
Investigations
Alanine aminotransferase increased
|
25.7%
9/35 • Number of events 10 • 7.5 years
|
|
Investigations
Creatinine increased
|
17.1%
6/35 • Number of events 6 • 7.5 years
|
|
Metabolism and nutrition disorders
Hyponatremia)
|
14.3%
5/35 • Number of events 6 • 7.5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/35 • Number of events 2 • 7.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.4%
4/35 • Number of events 4 • 7.5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Investigations
Blood bilirubin increased
|
11.4%
4/35 • Number of events 5 • 7.5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.4%
4/35 • Number of events 4 • 7.5 years
|
|
Investigations
Lipase increased
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased, upper extremity
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Nervous system disorders
Neuropathy: sensory
|
11.4%
4/35 • Number of events 4 • 7.5 years
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Nervous system disorders
Dizziness
|
25.7%
9/35 • Number of events 9 • 7.5 years
|
|
Nervous system disorders
Ataxia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Nervous system disorders
Altered mental status
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Eye disorders
Watering eyes
|
8.6%
3/35 • Number of events 3 • 7.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
5/35 • Number of events 6 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain- Joint
|
11.4%
4/35 • Number of events 5 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.1%
6/35 • Number of events 6 • 7.5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Renal and urinary disorders
Renal and urinary disorders -Other, specify Urethera pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
4/35 • Number of events 4 • 7.5 years
|
|
Ear and labyrinth disorders
External ear pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Nervous system disorders
Headache
|
20.0%
7/35 • Number of events 8 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
2.9%
1/35 • Number of events 2 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
General disorders
Pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic andmediastinal disorders - Other, specify paranasal sinus reactions
|
37.1%
13/35 • Number of events 13 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
5/35 • Number of events 6 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Number of events 2 • 7.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
25.7%
9/35 • Number of events 9 • 7.5 years
|
|
Psychiatric disorders
Libido
|
2.9%
1/35 • Number of events 1 • 7.5 years
|
|
Vascular disorders
Thromboembolic event
|
11.4%
4/35 • Number of events 4 • 7.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place