Trial Outcomes & Findings for Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma (NCT NCT00516217)
NCT ID: NCT00516217
Last Updated: 2016-07-06
Results Overview
Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Duration of treatment (up to 10 years)
Results posted on
2016-07-06
Participant Flow
Between June 2008 and January 2009, 30 patients were recruited.
One patient never received treatment and is excluded from all analyses.
Participant milestones
| Measure |
Galaximab
Induction: 500 mg/m\^2 by IV over 60 minutes days 1, 8, 15 \& 22 Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Galaximab
n=29 Participants
Induction: 500 mg/m\^2 by IV over 60 minutes days 1, 8, 15 \& 22 Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
|
|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 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
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment (up to 10 years)Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions.
Outcome measures
| Measure |
Galaximab
n=29 Participants
Induction: 500 mg/m\^2 by IV over 60 minutes days 1, 8, 15 \& 22 Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
|
|---|---|
|
Overall Response
|
3 participants
|
SECONDARY outcome
Timeframe: 12 monthsPercentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Galaximab
n=29 Participants
Induction: 500 mg/m\^2 by IV over 60 minutes days 1, 8, 15 \& 22 Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
|
|---|---|
|
12 Month Overall Survival Rate
|
79 percentage of participants
Interval 59.0 to 90.0
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method. Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion \> 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node.
Outcome measures
| Measure |
Galaximab
n=29 Participants
Induction: 500 mg/m\^2 by IV over 60 minutes days 1, 8, 15 \& 22 Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
|
|---|---|
|
6 Month Progression Free Survival Rate
|
21 percentage of participants
Interval 8.0 to 37.0
|
Adverse Events
Galaximab
Serious events: 8 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Galaximab
n=29 participants at risk
Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
|
|---|---|
|
Renal and urinary disorders
Urinary retention
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.9%
2/29 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.2%
5/29 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.9%
2/29 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
13.8%
4/29 • Number of events 9
|
|
Cardiac disorders
Cardiac disorder
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
6.9%
2/29 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
3.4%
1/29 • Number of events 1
|
|
Ear and labyrinth disorders
External ear pain
|
3.4%
1/29 • Number of events 1
|
|
Endocrine disorders
Adrenal insufficiency
|
3.4%
1/29 • Number of events 1
|
|
Endocrine disorders
Cushingoid
|
3.4%
1/29 • Number of events 2
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
1/29 • Number of events 1
|
|
Eye disorders
Vision blurred
|
6.9%
2/29 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
2/29 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • Number of events 4
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
3/29 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
17.2%
5/29 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • Number of events 5
|
|
General disorders
Chills
|
10.3%
3/29 • Number of events 5
|
|
General disorders
Edema limbs
|
6.9%
2/29 • Number of events 3
|
|
General disorders
Facial pain
|
3.4%
1/29 • Number of events 2
|
|
General disorders
Fatigue
|
20.7%
6/29 • Number of events 14
|
|
General disorders
Fever
|
20.7%
6/29 • Number of events 13
|
|
General disorders
General symptom
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Pain
|
10.3%
3/29 • Number of events 4
|
|
Immune system disorders
Autoimmune disorder
|
3.4%
1/29 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Anal infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
10.3%
3/29 • Number of events 4
|
|
Infections and infestations
Joint infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
6.9%
2/29 • Number of events 2
|
|
Infections and infestations
Sepsis
|
6.9%
2/29 • Number of events 2
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Wound infection
|
6.9%
2/29 • Number of events 2
|
|
Injury, poisoning and procedural complications
Bruising
|
3.4%
1/29 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
3/29 • Number of events 7
|
|
Investigations
Alkaline phosphatase increased
|
17.2%
5/29 • Number of events 10
|
|
Investigations
Aspartate aminotransferase increased
|
13.8%
4/29 • Number of events 10
|
|
Investigations
Blood bilirubin increased
|
6.9%
2/29 • Number of events 3
|
|
Investigations
Cardiac troponin T increased
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Creatinine increased
|
6.9%
2/29 • Number of events 5
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.3%
3/29 • Number of events 7
|
|
Investigations
INR increased
|
6.9%
2/29 • Number of events 4
|
|
Investigations
Leukocyte count decreased
|
6.9%
2/29 • Number of events 3
|
|
Investigations
Lipase increased
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
10.3%
3/29 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
10.3%
3/29 • Number of events 5
|
|
Investigations
Platelet count decreased
|
20.7%
6/29 • Number of events 14
|
|
Metabolism and nutrition disorders
Acidosis
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
13.8%
4/29 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
10.3%
3/29 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
13.8%
4/29 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
13.8%
4/29 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
13.8%
4/29 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
6.9%
2/29 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
3.4%
1/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
17.2%
5/29 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Number of events 5
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Number of events 4
|
|
Nervous system disorders
Neurological disorder NOS
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.9%
2/29 • Number of events 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.9%
2/29 • Number of events 4
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 5
|
|
Psychiatric disorders
Depression
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
1/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
6.9%
2/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.9%
2/29 • Number of events 2
|
|
Vascular disorders
Hypotension
|
10.3%
3/29 • Number of events 5
|
|
Vascular disorders
Thrombosis
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Galaximab
n=29 participants at risk
Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
3.4%
1/29 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
58.6%
17/29 • Number of events 33
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Cardiac pain
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
6.9%
2/29 • Number of events 17
|
|
Endocrine disorders
Adrenal insufficiency
|
3.4%
1/29 • Number of events 2
|
|
Endocrine disorders
Cushingoid
|
3.4%
1/29 • Number of events 3
|
|
Endocrine disorders
Hypothyroidism
|
6.9%
2/29 • Number of events 2
|
|
Eye disorders
Dry eye syndrome
|
3.4%
1/29 • Number of events 10
|
|
Eye disorders
Flashing vision
|
3.4%
1/29 • Number of events 1
|
|
Eye disorders
Vision blurred
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
2/29 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
20.7%
6/29 • Number of events 8
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
1/29 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
2/29 • Number of events 14
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Gastric mucositis
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
41.4%
12/29 • Number of events 24
|
|
Gastrointestinal disorders
Vomiting
|
17.2%
5/29 • Number of events 6
|
|
General disorders
Chills
|
20.7%
6/29 • Number of events 8
|
|
General disorders
Edema limbs
|
13.8%
4/29 • Number of events 15
|
|
General disorders
Fatigue
|
82.8%
24/29 • Number of events 52
|
|
General disorders
Fever
|
34.5%
10/29 • Number of events 13
|
|
General disorders
Localized edema
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Pain
|
3.4%
1/29 • Number of events 2
|
|
Infections and infestations
Anorectal infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
3.4%
1/29 • Number of events 2
|
|
Infections and infestations
Infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Infectious colitis
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Joint infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Lip infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Number of events 2
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
10.3%
3/29 • Number of events 3
|
|
Infections and infestations
Upper respiratory infection
|
6.9%
2/29 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruising
|
6.9%
2/29 • Number of events 5
|
|
Investigations
Alanine aminotransferase increased
|
27.6%
8/29 • Number of events 13
|
|
Investigations
Alkaline phosphatase increased
|
34.5%
10/29 • Number of events 20
|
|
Investigations
Aspartate aminotransferase increased
|
20.7%
6/29 • Number of events 12
|
|
Investigations
Blood bilirubin increased
|
6.9%
2/29 • Number of events 2
|
|
Investigations
Creatinine increased
|
13.8%
4/29 • Number of events 5
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
1/29 • Number of events 3
|
|
Investigations
Laboratory test abnormal
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
13.8%
4/29 • Number of events 7
|
|
Investigations
Lymphocyte count decreased
|
31.0%
9/29 • Number of events 16
|
|
Investigations
Neutrophil count decreased
|
6.9%
2/29 • Number of events 5
|
|
Investigations
Platelet count decreased
|
51.7%
15/29 • Number of events 38
|
|
Investigations
Serum cholesterol increased
|
6.9%
2/29 • Number of events 6
|
|
Investigations
Weight gain
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Weight loss
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
20.7%
6/29 • Number of events 9
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
48.3%
14/29 • Number of events 27
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.4%
1/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
24.1%
7/29 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
20.7%
6/29 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
6.9%
2/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
3.4%
1/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
20.7%
6/29 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
20.7%
6/29 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
5/29 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.9%
2/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
2/29 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.3%
3/29 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.3%
3/29 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
10.3%
3/29 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Number of events 3
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
6.9%
2/29 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
3.4%
1/29 • Number of events 2
|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Number of events 6
|
|
Nervous system disorders
Neuralgia
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.4%
1/29 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.8%
4/29 • Number of events 7
|
|
Nervous system disorders
Speech disorder
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 4
|
|
Psychiatric disorders
Depression
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
3.4%
1/29 • Number of events 1
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
3.4%
1/29 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • Number of events 1
|
|
Renal and urinary disorders
Urine discoloration
|
3.4%
1/29 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.9%
2/29 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.8%
13/29 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.4%
12/29 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
2/29 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.4%
1/29 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
3/29 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.7%
6/29 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
10.3%
3/29 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
6.9%
2/29 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.9%
2/29 • Number of events 3
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER