Trial Outcomes & Findings for A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study (NCT NCT02841748)
NCT ID: NCT02841748
Last Updated: 2026-05-13
Results Overview
Time from randomization to disease progression or death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
2 years (PFS at 2 years)
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient in the placebo arm had missing data.
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=49 Participants
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
n=51 Participants
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
n=49 Participants
|
64.8 years
n=51 Participants
|
62.4 years
n=100 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=49 Participants • One patient in the placebo arm had missing data.
|
16 Participants
n=50 Participants • One patient in the placebo arm had missing data.
|
33 Participants
n=99 Participants • One patient in the placebo arm had missing data.
|
|
Sex: Female, Male
Male
|
32 Participants
n=49 Participants • One patient in the placebo arm had missing data.
|
34 Participants
n=50 Participants • One patient in the placebo arm had missing data.
|
66 Participants
n=99 Participants • One patient in the placebo arm had missing data.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
4 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=49 Participants
|
5 Participants
n=51 Participants
|
8 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=49 Participants
|
40 Participants
n=51 Participants
|
79 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=49 Participants
|
2 Participants
n=51 Participants
|
3 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=49 Participants
|
4 Participants
n=51 Participants
|
6 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
51 participants
n=51 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 2 years (PFS at 2 years)Time from randomization to disease progression or death from any cause.
Outcome measures
| Measure |
Pembrolizumab
n=49 Participants
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
n=51 Participants
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
|---|---|---|
|
Progression Free Survival (PFS)
|
49.7 percentage of participants
Interval 34.6 to 63.1
|
35.3 percentage of participants
Interval 22.6 to 48.2
|
SECONDARY outcome
Timeframe: 2 years (PFS at 2 years)Population: Pre-specified measurement values were not obtained and will never be collected in the future. GES analysis was not done due do not having funding to undertake the gene sequencing.
Time from randomization to disease progression or death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years (PFS at 2 years)Time from randomization to disease progression or death from any cause.
Outcome measures
| Measure |
Pembrolizumab
n=15 Participants
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
n=22 Participants
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
|---|---|---|
|
Progression Free Survival (PFS) in PD-L1 >=10% Positive Patients
|
57.1 percentage of participants
Interval 28.4 to 78.0
|
40.9 percentage of participants
Interval 20.8 to 60.1
|
SECONDARY outcome
Timeframe: 2 years (OS at 2 years)Time from randomization to death from any cause
Outcome measures
| Measure |
Pembrolizumab
n=49 Participants
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
n=51 Participants
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
|---|---|---|
|
Overall Survival
|
82.8 percentage of participants
Interval 68.5 to 91.0
|
82.0 percentage of participants
Interval 68.3 to 90.2
|
SECONDARY outcome
Timeframe: 2 years (OS at 2 years)Population: Pre-specified measurement values were not obtained and will never be collected in the future. GES analysis was not done due do not having funding to undertake the gene sequencing.
Time from randomization to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years (OS at 2 years)Time from randomization to death from any cause.
Outcome measures
| Measure |
Pembrolizumab
n=15 Participants
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
n=22 Participants
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
|---|---|---|
|
Overall Survival (OS) in PD-L1 >=10% Positive Patients
|
85.7 percentage of participants
Interval 53.9 to 96.2
|
95.4 percentage of participants
Interval 71.9 to 99.4
|
Adverse Events
Pembrolizumab
Serious events: 9 serious events
Other events: 47 other events
Deaths: 13 deaths
Placebo
Serious events: 11 serious events
Other events: 51 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=49 participants at risk
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
n=51 participants at risk
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.1%
2/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
General disorders
Facial pain
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
General disorders
Fatigue
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Injury to carotid artery
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Investigations
INR increased
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Infections and infestations
Lung infection
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Vascular disorders
Vascular disorders - Other
|
2.0%
1/49 • Up to 4 years
|
0.00%
0/51 • Up to 4 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
Other adverse events
| Measure |
Pembrolizumab
n=49 participants at risk
200mg, every three weeks, iv, x 1 year
Pembrolizumab: 200mg, every three weeks, iv, x 1 year
|
Placebo
n=51 participants at risk
iv, every 3 weeks, x 1 year
Placebo: iv, every three weeks, x 1 year
|
|---|---|---|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
2.0%
1/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
12.2%
6/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Infections and infestations
Upper respiratory infection
|
10.2%
5/49 • Up to 4 years
|
13.7%
7/51 • Up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
4/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Investigations
Weight gain
|
4.1%
2/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Investigations
Weight loss
|
12.2%
6/49 • Up to 4 years
|
17.6%
9/51 • Up to 4 years
|
|
Investigations
White blood cell decreased
|
6.1%
3/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
7/49 • Up to 4 years
|
11.8%
6/51 • Up to 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
10.2%
5/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Renal and urinary disorders
Acute kidney injury
|
4.1%
2/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
6.1%
3/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.2%
4/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Psychiatric disorders
Anxiety
|
6.1%
3/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.4%
9/49 • Up to 4 years
|
15.7%
8/51 • Up to 4 years
|
|
Investigations
Asparate aminotransferase increased
|
6.1%
3/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.3%
8/49 • Up to 4 years
|
11.8%
6/51 • Up to 4 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic tissue disorders - Other
|
6.1%
3/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Eye disorders
Blurred vision
|
4.1%
2/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Gastrointestinal disorders
Chills
|
8.2%
4/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Gastrointestinal disorders
Colitis
|
10.2%
5/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
14.3%
7/49 • Up to 4 years
|
23.5%
12/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.5%
12/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Investigations
Creatinine increased
|
2.0%
1/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
3/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Psychiatric disorders
Depression
|
2.0%
1/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.3%
8/49 • Up to 4 years
|
37.3%
19/51 • Up to 4 years
|
|
Nervous system disorders
Dizziness
|
12.2%
6/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Eye disorders
Dry eye
|
4.1%
2/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
12.2%
6/49 • Up to 4 years
|
13.7%
7/51 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.2%
5/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Nervous system disorders
Dysgeusia
|
4.1%
2/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
16.3%
8/49 • Up to 4 years
|
15.7%
8/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.2%
6/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorder - Other
|
0.00%
0/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Ear and labyrinth disorders
Ear pain
|
6.1%
3/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
General disorders
Edema face
|
4.1%
2/49 • Up to 4 years
|
11.8%
6/51 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.1%
3/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Eye disorders
Eye disorders - Other
|
8.2%
4/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
General disorders
Facial pain
|
8.2%
4/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
3/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
General disorders
Fatigue
|
49.0%
24/49 • Up to 4 years
|
60.8%
31/51 • Up to 4 years
|
|
General disorders
Fever
|
14.3%
7/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.1%
3/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
18.4%
9/49 • Up to 4 years
|
19.6%
10/51 • Up to 4 years
|
|
General disorders
General disorders and administration site conditions - Other
|
8.2%
4/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.1%
2/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Nervous system disorders
Headache
|
12.2%
6/49 • Up to 4 years
|
27.5%
14/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.2%
4/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.1%
3/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Vascular disorders
Hypertension
|
6.1%
3/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.1%
2/49 • Up to 4 years
|
11.8%
6/51 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.0%
1/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Endocrine disorders
Hypothyroidism
|
22.4%
11/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Infections and infestations
Infections and infestations - Other
|
6.1%
3/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications - Other
|
6.1%
3/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Psychiatric disorders
Insomnia
|
8.2%
4/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Investigations
Investigations - Other
|
2.0%
1/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
General disorders
Localized edema
|
0.00%
0/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Vascular disorders
Lymphedema
|
6.1%
3/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
General disorders
Malaise
|
2.0%
1/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
7/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other
|
10.2%
5/49 • Up to 4 years
|
13.7%
7/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
4/49 • Up to 4 years
|
13.7%
7/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.2%
4/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
20.4%
10/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
General disorders
Neck edema
|
4.1%
2/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
3/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
General disorders
Non-cardiac chest pain
|
10.2%
5/49 • Up to 4 years
|
3.9%
2/51 • Up to 4 years
|
|
General disorders
Oral dysesthesia
|
4.1%
2/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Gastrointestinal disorders
Oral pain
|
12.2%
6/49 • Up to 4 years
|
25.5%
13/51 • Up to 4 years
|
|
General disorders
Pain
|
18.4%
9/49 • Up to 4 years
|
17.6%
9/51 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
4/49 • Up to 4 years
|
11.8%
6/51 • Up to 4 years
|
|
Nervous system disorders
Paresthesia
|
4.1%
2/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.2%
6/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/49 • Up to 4 years
|
5.9%
3/51 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
14.3%
7/49 • Up to 4 years
|
15.7%
8/51 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
7/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.4%
10/49 • Up to 4 years
|
11.8%
6/51 • Up to 4 years
|
|
Renal and urinary disorders
Renal and urinary disorder - Other
|
6.1%
3/49 • Up to 4 years
|
2.0%
1/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders - Other
|
2.0%
1/49 • Up to 4 years
|
9.8%
5/51 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders - Other
|
18.4%
9/49 • Up to 4 years
|
21.6%
11/51 • Up to 4 years
|
|
Infections and infestations
Skin infection
|
6.1%
3/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.3%
7/49 • Up to 4 years
|
7.8%
4/51 • Up to 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60