Trial Outcomes & Findings for Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NCT NCT00553501)
NCT ID: NCT00553501
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
60 participants
Primary outcome timeframe
12 months
Results posted on
2016-07-06
Participant Flow
Between March 2008 and July 2009, 60 participants were recruited.
One participant was deemed ineligible and excluded from all analyses per study design.
Participant milestones
| Measure |
Epratuzumab Plus Rituximab
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Epratuzumab Plus Rituximab
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Progression
|
1
|
Baseline Characteristics
Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Epratuzumab Plus Rituximab
n=59 Participants
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
Age, Continuous
|
54 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOverall 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 |
Epratuzumab Plus Rituximab
n=59 Participants
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
Number of Participants With Overall Response
Complete Response
|
25 participants
|
|
Number of Participants With Overall Response
Partial Response
|
27 participants
|
SECONDARY outcome
Timeframe: Duration of study (up to 10 years)Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Epratuzumab Plus Rituximab
n=59 Participants
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
Progression Free Survival
|
3.5 years
Interval 2.6 to 4.4
|
POST_HOC outcome
Timeframe: 3 yearsPercentage of participants who were alive at 3 years. The 3 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Epratuzumab Plus Rituximab
n=59 Participants
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
3-Year Overall Survival
|
91 percentage of participants
Interval 80.0 to 96.0
|
Adverse Events
Epratuzumab Plus Rituximab
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epratuzumab Plus Rituximab
n=59 participants at risk
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
10.2%
6/59 • Number of events 7
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/59 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
1.7%
1/59 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
1.7%
1/59 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/59 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
2/59 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
5.1%
3/59 • Number of events 4
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Number of events 2
|
|
General disorders
Edema limbs
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Fatigue
|
13.6%
8/59 • Number of events 9
|
|
General disorders
Fever
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Localized edema
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Pain
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Visceral edema
|
1.7%
1/59 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
1.7%
1/59 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Endocarditis infective
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Infection
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Peripheral nerve infection
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
2/59 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
3.4%
2/59 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
5.1%
3/59 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
3.4%
2/59 • Number of events 2
|
|
Investigations
Cardiac troponin I increased
|
3.4%
2/59 • Number of events 2
|
|
Investigations
Creatinine increased
|
3.4%
2/59 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
1.7%
1/59 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
3.4%
2/59 • Number of events 2
|
|
Investigations
Platelet count decreased
|
5.1%
3/59 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/59 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
8.5%
5/59 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.4%
2/59 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
3.4%
2/59 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
3.4%
2/59 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.7%
1/59 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.7%
1/59 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.7%
1/59 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/59 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.1%
3/59 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.4%
2/59 • Number of events 2
|
|
Nervous system disorders
Mini mental status examination abnormal
|
1.7%
1/59 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Number of events 1
|
|
Renal and urinary disorders
Bladder hemorrhage
|
1.7%
1/59 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
3/59 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
3/59 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.7%
1/59 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.4%
2/59 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
1.7%
1/59 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.7%
1/59 • Number of events 1
|
|
Vascular disorders
Hypotension
|
3.4%
2/59 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
3.4%
2/59 • Number of events 2
|
Other adverse events
| Measure |
Epratuzumab Plus Rituximab
n=59 participants at risk
Induction Therapy (Month 1):
Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
25.4%
15/59 • Number of events 37
|
|
Blood and lymphatic system disorders
Lymph node pain
|
11.9%
7/59 • Number of events 13
|
|
Cardiac disorders
Cardiac disorder
|
3.4%
2/59 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
1.7%
1/59 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
1.7%
1/59 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
1.7%
1/59 • Number of events 3
|
|
Eye disorders
Eye disorder
|
1.7%
1/59 • Number of events 2
|
|
Eye disorders
Vision blurred
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
3/59 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
16.9%
10/59 • Number of events 14
|
|
Gastrointestinal disorders
Constipation
|
18.6%
11/59 • Number of events 21
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
5/59 • Number of events 10
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
2/59 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
5/59 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.1%
3/59 • Number of events 3
|
|
Gastrointestinal disorders
Gingival pain
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
35.6%
21/59 • Number of events 29
|
|
Gastrointestinal disorders
Stomach pain
|
1.7%
1/59 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
6/59 • Number of events 8
|
|
General disorders
Chills
|
13.6%
8/59 • Number of events 8
|
|
General disorders
Edema limbs
|
10.2%
6/59 • Number of events 10
|
|
General disorders
Fatigue
|
59.3%
35/59 • Number of events 100
|
|
General disorders
Fever
|
18.6%
11/59 • Number of events 15
|
|
General disorders
Flu-like symptoms
|
1.7%
1/59 • Number of events 1
|
|
General disorders
General symptom
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Pain
|
10.2%
6/59 • Number of events 9
|
|
Immune system disorders
Cytokine release syndrome
|
8.5%
5/59 • Number of events 9
|
|
Immune system disorders
Hypersensitivity
|
3.4%
2/59 • Number of events 4
|
|
Immune system disorders
Immune system disorder
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
3.4%
2/59 • Number of events 2
|
|
Infections and infestations
Catheter related infection
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Infection
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Otitis media
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
10.2%
6/59 • Number of events 11
|
|
Infections and infestations
Urinary tract infection
|
5.1%
3/59 • Number of events 3
|
|
Infections and infestations
Vaginal infection
|
1.7%
1/59 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/59 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.7%
1/59 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
11.9%
7/59 • Number of events 19
|
|
Investigations
Alkaline phosphatase increased
|
6.8%
4/59 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
18.6%
11/59 • Number of events 22
|
|
Investigations
Blood bilirubin increased
|
22.0%
13/59 • Number of events 29
|
|
Investigations
Creatinine increased
|
6.8%
4/59 • Number of events 15
|
|
Investigations
Laboratory test abnormal
|
8.5%
5/59 • Number of events 12
|
|
Investigations
Leukocyte count decreased
|
20.3%
12/59 • Number of events 28
|
|
Investigations
Lymphocyte count decreased
|
16.9%
10/59 • Number of events 18
|
|
Investigations
Neutrophil count decreased
|
10.2%
6/59 • Number of events 13
|
|
Investigations
Platelet count decreased
|
20.3%
12/59 • Number of events 24
|
|
Investigations
Weight loss
|
1.7%
1/59 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
2/59 • Number of events 2
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
37.3%
22/59 • Number of events 60
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
6.8%
4/59 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
2/59 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
11.9%
7/59 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
11.9%
7/59 • Number of events 13
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
3.4%
2/59 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
11.9%
7/59 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
8.5%
5/59 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
15.3%
9/59 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
15.3%
9/59 • Number of events 14
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
22.0%
13/59 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
7/59 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.6%
11/59 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
2/59 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.2%
6/59 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
3/59 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.5%
5/59 • Number of events 6
|
|
Nervous system disorders
Dysgeusia
|
3.4%
2/59 • Number of events 3
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Headache
|
15.3%
9/59 • Number of events 13
|
|
Nervous system disorders
Memory impairment
|
1.7%
1/59 • Number of events 2
|
|
Nervous system disorders
Neuralgia
|
1.7%
1/59 • Number of events 5
|
|
Nervous system disorders
Neurological disorder NOS
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.9%
7/59 • Number of events 11
|
|
Nervous system disorders
Tremor
|
1.7%
1/59 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
1.7%
1/59 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
10.2%
6/59 • Number of events 8
|
|
Psychiatric disorders
Depression
|
3.4%
2/59 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
13.6%
8/59 • Number of events 17
|
|
Psychiatric disorders
Libido decreased
|
1.7%
1/59 • Number of events 2
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
1.7%
1/59 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
1.7%
1/59 • Number of events 2
|
|
Renal and urinary disorders
Urine discoloration
|
1.7%
1/59 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
6.8%
4/59 • Number of events 4
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.2%
6/59 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.9%
10/59 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.2%
6/59 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.1%
3/59 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
1/59 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
2/59 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.7%
1/59 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
11/59 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
10.2%
6/59 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
8.5%
5/59 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Sweating
|
8.5%
5/59 • Number of events 8
|
|
Vascular disorders
Flushing
|
3.4%
2/59 • Number of events 3
|
|
Vascular disorders
Hot flashes
|
8.5%
5/59 • Number of events 10
|
|
Vascular disorders
Hypertension
|
6.8%
4/59 • Number of events 8
|
|
Vascular disorders
Hypotension
|
3.4%
2/59 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60