Trial Outcomes & Findings for Pembrolizumab in Combination With CRT for LA-SCCHN (NCT NCT02586207)
NCT ID: NCT02586207
Last Updated: 2025-10-07
Results Overview
To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Number of participants affected by AEs will be reported by grade and percentage of participants affected. Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment)
Results posted on
2025-10-07
Participant Flow
Participant milestones
| Measure |
Single Arm
Pembrolizumab + Cisplatin + Radiation
pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Radiation: 70 Gy fractionated over 35 days
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Arm
Pembrolizumab + Cisplatin + Radiation
pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Radiation: 70 Gy fractionated over 35 days
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pembrolizumab in Combination With CRT for LA-SCCHN
Baseline characteristics by cohort
| Measure |
Single Arm
n=59 Participants
Pembrolizumab + Cisplatin + Radiation
pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Radiation: 70 Gy fractionated over 35 days
|
|---|---|
|
Age, Continuous
|
59.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 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
|
PRIMARY outcome
Timeframe: through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment)Population: Number of participants who experience an Adverse Event.
To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Number of participants affected by AEs will be reported by grade and percentage of participants affected. Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.
Outcome measures
| Measure |
Single Arm
n=57 Participants
Pembrolizumab + Cisplatin + Radiation
pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Radiation: 70 Gy fractionated over 35 days
|
|---|---|
|
Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.
|
57 Participants
|
SECONDARY outcome
Timeframe: Day 150 (post treatment imaging)Response was determined using a composite end point of overall end-of-treatment (EOT) complete response (CR) at day 150 (approximately 12 weeks after completion of chemoradiotherapy) by CT of the neck (RECIST 1.1). Optional positron emission tomography (PET) imaging was allowed rather than neck dissection if CT could not confirm CR. Complete metabolic response was assessed using Hopkins score of 1, 2, or 3 on PET imaging. For those without an imaging CR, pathologic confirmation was recommend (but not required) by selective neck dissection and/or directed biopsy of the suspected active disease site. If pathologic evaluation of the potential disease site confirmed no residual invasive or in situ cancer, the patient was determined to have a pathologic CR. In cases with both an imaging CR and pathologic response assessment, the pathologic response defined final overall response. Therefore, patients with a final EOT CR included those with either an imaging (CT or PET) or pathologic CR.
Outcome measures
| Measure |
Single Arm
n=57 Participants
Pembrolizumab + Cisplatin + Radiation
pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Radiation: 70 Gy fractionated over 35 days
|
|---|---|
|
Evaluation of the Efficacy of Pembrolizumab Given in Combination With Definitive CRT by Determining the Number of Participants With Complete Response at Treatment End (Day 150)
|
47 Participants
|
Adverse Events
Single Arm
Serious events: 28 serious events
Other events: 59 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Single Arm
n=59 participants at risk
Pembrolizumab + Cisplatin + Radiation
pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Radiation: 70 Gy fractionated over 35 days
|
|---|---|
|
Endocrine disorders
Adrenal Insufficiency
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Aspiratoin Pneumonia
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Cardiac disorders
cardiac arrest
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Dehydration
|
11.9%
7/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Dysphagia
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Infections and infestations
Encephalitis Infection
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Fever
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
GI Bleed
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hyponatrimia
|
3.4%
2/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Ileus
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
3.4%
2/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Lowet gastrointestinal hemorrhage
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Pain
|
3.4%
2/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Cardiac disorders
Palpitations
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Syncope
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Vascular disorders
Thromboembolic event
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Weight Loss
|
1.7%
1/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
Other adverse events
| Measure |
Single Arm
n=59 participants at risk
Pembrolizumab + Cisplatin + Radiation
pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Radiation: 70 Gy fractionated over 35 days
|
|---|---|
|
Investigations
Lymphocyte Count Decreased
|
98.3%
58/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Blood and lymphatic system disorders
Anemia
|
94.9%
56/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
White Blood Cell Decreased
|
93.2%
55/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Dysphagia
|
86.4%
51/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Weight Loss
|
84.7%
50/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
88.1%
52/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Dry Mouth
|
84.7%
50/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Fatigue
|
86.4%
51/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Nausea
|
81.4%
48/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Mucositis oral
|
81.4%
48/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Dysgeusia
|
79.7%
47/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hyponatremia
|
76.3%
45/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Constipation
|
69.5%
41/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Salivary Duct Inflammation
|
69.5%
41/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
neutrophil count decreased
|
66.1%
39/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Vomiting
|
59.3%
35/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
61.0%
36/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Anorexia
|
57.6%
34/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Platelet count decreased
|
57.6%
34/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
55.9%
33/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Alanine aminotransferase increased
|
23.7%
14/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Alkaline phosphatase increased
|
11.9%
7/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.4%
15/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Psychiatric disorders
Anxiety
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Aspartate aminotransferase increased
|
16.9%
10/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
11.9%
7/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Ear and labyrinth disorders
Ear pain
|
13.6%
8/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Ear and labyrinth disorders
Hearing impaired
|
15.3%
9/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Ear and labyrinth disorders
Tinnitus
|
32.2%
19/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Eye disorders
Blurred vision
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Eye disorders
Dry Eye
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Endocrine disorders
Hyperthyroidism
|
16.9%
10/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Endocrine disorders
Hypothyroidism
|
35.6%
21/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Chills
|
18.6%
11/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Colitis
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Diarrhea
|
49.2%
29/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
8/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Edema Limbs
|
13.6%
8/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Fever
|
15.3%
9/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Flu like symptoms
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.2%
6/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Malaise
|
8.5%
5/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
Neck edema
|
10.2%
6/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Gastrointestinal disorders
Oral pain
|
27.1%
16/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
General disorders
pain
|
32.2%
19/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Injury, poisoning and procedural complications
Fall
|
11.9%
7/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Infections and infestations
Mucosal infection
|
32.2%
19/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Infections and infestations
Skin Infection
|
10.2%
6/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Blood bilirubin increased
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Creatinine increased
|
15.3%
9/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Investigations
Lymphocyte count increased
|
15.3%
9/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Dehydration
|
49.2%
29/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.2%
6/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
22.0%
13/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
39.0%
23/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.0%
13/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.6%
21/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.4%
15/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
5/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.9%
10/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.2%
6/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.6%
8/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
15.3%
9/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Headache
|
22.0%
13/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Paresthesia
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.7%
14/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Syncope
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Psychiatric disorders
Confusion
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Psychiatric disorders
Depression
|
18.6%
11/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Psychiatric disorders
Insomnia
|
28.8%
17/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Renal and urinary disorders
Hematuria
|
18.6%
11/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Renal and urinary disorders
Proteinuria
|
35.6%
21/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Renal and urinary disorders
Urinary frequency
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.8%
17/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.3%
9/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
15.3%
9/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.2%
6/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.9%
7/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.5%
5/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
39.0%
23/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.1%
3/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
20.3%
12/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Vascular disorders
Hot flashes
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Vascular disorders
Hypertension
|
6.8%
4/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Vascular disorders
Hypotension
|
23.7%
14/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Vascular disorders
Lymphedema
|
42.4%
25/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
|
Nervous system disorders
Dizziness
|
27.1%
16/59 • Enrollment through Day 150 plus 90 days for SAE reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place